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Parastomal hernia: investigation and treatment
Pia Näsvall
Department of Surgery and Perioperative Sciences
Umeå 2015
Responsible publisher under swedish law: the Dean of the Medical Faculty
This work is protected by the Swedish Copyright Legislation (Act 1960:729)
Umeå University Medical Dissertations
New Series No 1707
Copyright: Pia Näsvall
ISBN: 978-91-7601-241-3
ISSN: 0346-6612
Cover picture by Åsa Lundin
Electronic version available at://umu.diva-portal.org/
Printed by: Print & Media
Umeå University, SE-901 87 Umeå, Sweden
“Never measure the height of a mountain, until you have reached the top.
Then you will see how low it was.”
Dag Hammarskjöld
i
Table of Contents
Table of Contents i Abstract ii List of Abbreviations iv Sammanfattning på svenska vii Introduction and background 11
Investigation 3 Surgical treatment 5 Quality of life 8
List of Publications 10 Aims of this Thesis 11 Patients and methods 120
Studies I and II 1Fel! Bokmärket är inte definierat. Study I 1Fel! Bokmärket är inte definierat. Study II 14 Study III 14 Study IV 15
Results 17 Study I 17 Study II 18 Study III 19 Study IV 22
Discussion and Future aspects 23 Acknowledgements 28 References 29
ii
Abstract
Background
Parastomal hernia is a common stoma complication causing the patient
considerable inconvenience. The patient becomes aware of a bulge around
the stoma, but a bulge is not always a parastomal hernia and diagnostics
must be performed to enable differential treatment. It is difficult to
distinguish between a bulge and a hernia. Results based on clinical
examination and computerised tomography (CT) in the supine position, have
not been convincing. Three-dimensional intrastomal ultrasonography (3D
US) is a novel technique shown to be promising in the assessment of stoma
complaints. Two studies were performed to determine inter- and intra-
observer reliability as well as the validity of 3D US as an alternative to CT
when assessing stoma complaints.
There are numerous options for the treatment of parastomal hernia, but
none has been shown superior. In the recent decades the use of mesh in the
repair of incisional and inguinal hernia has become routine. New materials
must be evaluated as there are potential morbidity and even mortality risks
with mesh repair. As recurrence of a parastomal hernia is an even greater
challenge, the method of choice should have a low risk for recurrence. A
prospective multicenter study was performed to evaluate safety and
recurrence rate when using Parastomal Hernia Patch BARDTM (PHP), a
mesh specially designed for parastomal hernia repair,.
A stoma has a profound impact on the patient´s daily life, both physical and
psychological. A parastomal hernia with its associated risk for leakage and
incarceration worsens the situation. Patient driven assessment of healthcare
outcome is important if we are to improve medical care. A quality of life
(QoL) survey was performed to assess the impact of parastomal bulging and
hernia on the patient´s daily life.
Methods
Forty patients were investigated and the 3D US images were twice evaluated
by two or three physicians to assess inter- and intra-observer reliability.
Totally 20 patients with stoma complaints requiring surgery were examined
with CT and 3D US prior to surgery. The findings were compared with the
intraoperative findings – regarded as the true outcome.
iii
Fifty patients with parastomal hernia requiring surgery were enrolled from
three hospitals. Patients were followed up one month and one year after
repair using PHP.
Patients still alive in 2008 who had been operated between1996 and 2004
for rectal cancer in Uppsala/Örebro-, Stockholm/Gotland-, and Northern
Regions (986 patients) and registered in the Swedish Rectal Cancer Registry
(SRCR) were invited to fill in four QoL questionnaires.
Results
Inter-observer agreement using 3D US reached 80% for the last 10 patients
examined, with a kappa value of 0.70. Intra-observer agreement for two
examiners was 80% and 95%. The learning curve levelled out at 30 patients.
Both CT and 3D US showed high sensitivity and specificity when compared
with intraoperative findings.
After surgery for parastomal hernia with a PHP, the complication rate at one
month was 30% and recurrence rate at one year was 22%. Twelve patients
were reoperated within one year.
In the QoL study, 31.5% of the patients with a stoma reported a bulging or a
hernia. 11.7% had been operated for parastomal hernia. A hernia or a bulge
gave rise to significantly more pain and impaired stoma function. Overall
QoL was inferior in patients with a permanent stoma compared to a group
without a stoma.
iv
List of Abbreviations
3D US Three-dimensional intrastomal ultrasonography
AP Loss of appetite
ASA American Society of Anesthesiologists physical classification
system
BI Body image
BMI Body mass index
BP Bodily pain
CF Cognitive function
cIH Concomitant incisional hernia
CO Constipation
CT Chemotherapy side-effects
DF Defaecation problems
DI Diarrhoea
DY Dyspnoea
EHS European Hernia Society
EORTC European Organisation for Research and Treatment of Cancer
QLQ-C30 Quality-of-Life Questionnaire for Cancer
QLQ-C38 Quality-of-Life Questionnaire for Colorectal
cancer
ePTFE Polytetrafluoroethylene
ERF Emotional role function
v
FA Fatigue
FI Financial impact
FP Future perspective
FSX Female sexual problems
Gen General health
GI Gastrointestinal symptoms
HA Hartmann’s operation
HAL Health Assessment Lab
HRQoL Health-related quality-of-life
IPOM Intraperitoneal on-lay mesh
LR+ Positive likelihood ratio
mcs Mental component summary
MH Mental health
MHz Megahertz
MI Micturating problems
MOT Medical Outcome Trust
NPV Negative predictive value
MSX Male sexual problems
NV Nausea and vomiting¨
PA Pain
pcs Physical component summary
PF Physical function
vi
PHP Parastomal Hernia Patch BARDTM
PPV Positive predictive value
PRF Physical role function
QoL Quality-of-life
RF Role function
SE Sexual enjoyment
SF Social function
SF-36 Short Form 36 questionnaire
SL Insomnia
SQ Stoma Questionnaire
SRCR Swedish Rectal Cancer Register
STO Stoma-related problems
SX Sexual function
USB Universal serial bus
V Vitality
WL Weight loss
vii
Sammanfattning på svenska
En stomi innebär att en tarmände dragits fram genom bukväggen och fästs i
huden för att avföringen ska komma ut den vägen. I akuta situationer med
svår infektion i bukhålan kan en stomi vara livräddande och i många fall
tillfällig. Dock förblir en stor andel av dessa permanenta. Behandling av
ändtarmscancer innebär i ungefär 30 % av fallen att patienten får en
permanent stomi efter operation, andra orsaker till stomi-operation är
inflammatorisk tarmsjukdom (Crohns sjukdom och ulcerös kolit),
inkontinens m fl. I Norrbotten får ungefär 130 patienter årligen en stomi och
om man extrapolerar antalet för hela Sverige landar man på fler än 4500
varje år. Det finns en mängd olika stomipåsar för bandagering och de flesta
sjukhus har stomi-terapeuter som kan stötta patienten och hjälpa till med
utprovning av lämpliga hjälpmedel. Själva placeringen av stomin på
bukväggen är viktig för att påsen ska sitta bra och inte orsaka läckage som i
sig kan vara mycket besvärande och generande.
I många fall fungerar stomin mycket bra men det finns komplikationer
kopplade till stomier. Ett bråck vid stomin kallas parastomalt bråck. Bråck
förekommer på lokalisationer där det finns en försvagning av bukväggen till
exempel i ljumskar och vid naveln där ofta medfödda försvagningar finns.
Bråck kan också uppstå vid förvärvade försvagningar efter tidigare
operationer och stomiöppningar då ett hål skapas genom bukväggen för
stomitarmen. Detta kan ge besvär i form av att det putar ut, att det smärtar
och det finns risk för inklämning av tarm eller annan del av bukhålans
innehåll, oftast fett. Inklämning kan kräva akut operation då cirkulationen
till den vävnad som klämts in kan vara hotad.
Parastomala bråck är vanliga, men riktigt hur vanliga är inte med säkerhet
fastställt. I litteraturen förekommer uppgifter att mellan några få procent
upp till drygt 70 procent av patienter med stomi utvecklar parastomalt
bråck. Om den sanna siffran är 50 % skulle drygt 2000 patienter utveckla
parastomala bråck i Sverige varje år. Det patienten märker av är oftast en
buktning kring själva stomin men om det är ett bråck eller en buktning utan
samtidigt bråck kan är svårt att avgöra med endast klinisk undersökning. Då
behandlingen av ett parastomalt bråck och en buktning bör skiljas åt bör
också diagnostiken av parastomala bråck vara god. Skiktröntgen av buken
(CT) är idag en rutinundersökning och ingår som utredning inför behandling
av och uppföljning efter ändtarmscancer, liksom vid en mängd andra
tillstånd. De studier man gjort avseende CT i ryggläge för diagnostik av
parastomala bråck visar dock på svårighetermed diagnostiken. Man har
också studerat CT liggande på mage och då visat på en högre känslighet för
viii
att upptäcka bråck. Nackdelar med CT är det faktum att patienten utsätts för
strålning samt att rutinmässiga undersökningar utförs i ryggläge.
Ultraljudsundersökningar har fördelen att inte utsätta patienten för
strålning. Tre-dimensionellt ultraljud har under en längre tid använts för
endoanala och endorektala undersökningar. Tre-dimensionellt intrastomalt
ultraljud (3D US) är en ny utveckling av metoden för att undersöka stomala
besvär. Undersökningen kan utföras dynamiskt, dvs. om bråck/buktning
uppkommer vid t ex hostning kan själva bildupptagningen göras under
hoststöt, och i direkt anslutning till den kliniska undersökningen.
De två första arbetena i avhandlingen handlar om 3D US och parastomala
besvär.
Arbete ett är en undersökning av hur stor överensstämmelsen var vid
bedömning av bilder vid upprepade tolkningstillfällen hos samma bedömare,
den sk intrabedömar-reliabiliteten, och mellan två olika bedömare –
interbedömar-reliabilitet. Totalt 40 patienter med besvär kopplade till sin
stomi deltog i studien. Samtliga undersöktes med 3D US och bildmaterialet
bedömdes därefter av två bedömare vid två tillfällen med en månads
mellanrum. Slutsatsen var att efter ca trettio undersökningar nåddes
inlärningskurvans platå och man hade en god överensstämmelse mellan
bedömningar både för samma bedömare och mellan de två bedömarna.
I delarbete två fastställdes validiteten av 3D US dvs.: mäter 3D US det vi vill
eller önskar mäta. Tjugo patienter med besvär kopplade till stomin som
grund för beslut om operativ åtgärd inkluderades i undersökningen.
Samtliga patienter undersöktes innan operation kliniskt, med CT i ryggläge
och med 3D US. Fynden vid operationen betraktades som det sanna utfallet
och jämfördes sedan med fynden på CT och 3D US. Resultaten visade på hög
känslighet (sensitivitet) för parastomala bråck både för CT och 3D US. Även
specificiteten var god. Dock kan man inte säkert säga att ett normalt
undersökningsfynd också utesluter parastomalt bråck (specificitet) då det
endast var patienter med besvär som ingick i studien.
Behandlingsalternativen för parastomala bråck är många, men inget har
visat sig vara överlägset. Under de senaste decennierna har olika nät-
metoder blivit rutin för att behandla ärrbråck och ljumskbråck. Nya
varianter av nät och nätmaterial utvecklas ständigt och det är viktigt att
utvärdera nyttan och riskerna med dessa då det finns möjlig risk för både
komplikationer och död kopplat till användande av nät. Nät som behandling
av parastomala bråck finns beskrivet redan 1977 och även inom detta
område sker en ständig utveckling. Olika nät har testats i relativt små studier
ix
utan att något visat sig vara överlägset. Risken för komplikationer kopplat
till näten har visat sig vara betydande liksom även risken för att på nytt
utveckla ett parastomalt bråck, sk recidiv.
I det tredje arbetet i avhandlingen undersöks säkerhet och recidivrisk med
ett nät designat för behandling av parastomala bråck: Parastomal Hernia
Patch BARDTM (PHP). Femtio patienter med parastomala bråck opereras
med PHP under perioden 2008 till januari 2014. Patienterna följs sedan upp
efter en månad med klinisk undersökning och efter ett år med klinisk
undersökning och CT. Resultaten var nedslående med recidiv av parastomalt
bråck hos 30 % av patienterna redan efter ett år. 22 % av patienterna fick
någon form av komplikation och 12 % blev omopererade inom ett år.
Slutsaten blev att PHP inte tycks vara det optimala nätet för behandling av
parastomala bråck. Dock skiljer sig resultaten inte avsevärt från tidigare
studier.
Att leva med en stomi påverkar livskvaliten för många patienter. Livskvalité
är dock ett svårt mått och en högst personlig upplevelse och upplevd god
livskvalité måste inte innebära perfekt hälsa. Det finns ett talesätt: ”Det är
inte hur man har det, utan hur man tar det” som påverkar hur man upplever
sin situation. Trots detta är det av stor vikt att förstå hur olika sjukdomar och
behandlingar påverkar patienterna för att kunna förbättra vården ytterligare.
Ett antal olika frågeformulär har utvecklats för att mäta livskvalité (QoL).
Det fjärde arbetet är en QoL-studie av patienter vid liv 2008, som under
perioden 1996-2004 opererats för ändtarmscancer med eller utan
permanent stomi. Särskild tonvikt lades på de som hade bråck/buktning
kring sin stomi. 986 patienter (768 med stomi och 218 utan) fick 4 olika
QoL-formulär, totalt 453 patienter (336 med stomi och 117 utan) svarade på
enkäterna. Svarsfrekvensen, 46 %, gör att viss försiktighet bör iakttas om
resultaten generaliseras. En tredjedel hade ett bråck eller en buktning kring
sin stomi och 12 % hade opererats på grund av parastomalt bråck. Mental
hälsa, kroppsuppfattning liksom känslomässig funktion var sämre i gruppen
med stomi. Tidigare studier har visat på sexuella problem hos patienter med
stomi, den här studien visade dock sämre funktion hos individer utan stomi.
Däremot tycktes bråck/buktning ha negativ påverkan på den sexuella
funktionen. Bråck/buktning var förknippad med smärta och en oro för
läckage från stomin påverkade hur man upplevde stomifunktionen.
Övergripande QoL var sämre i gruppen med permanent stomi jämfört med
gruppen utan stomi och ett bråck eller buktning försämrade ytterligare QoL.
x
Parastomala bråck är svårbehandlade och det är viktigt att nya metoder
utvecklas och utvärderas. Lovande material är biologiska material och
patientegen vävnad. Diagnostiken bör också förfinas och ytterligare
utvärdering av 3D US är planerad. En studie planeras där patienter med
stomi, med och utan problem relaterade till stomin, undersöks med 3D US
innan planerad bukkirurgi. Att kunna förebygga uppkomst av parastomala
bråck vore bra. Studier har visat lovande resultat med ett nät för att skydda
mot bråck i samband med den primära stomioperationen. Dock har det
under senaste året kommit en rapport om oförändrad frekvens parastomala
bråck med eller utan nät. STOMAMESH är en stor svensk studie, utgående
från Sunderby sjukhus, där lottning sker mellan nät eller inte i samband med
den primära stomioperationen. Flera sjukhus deltar och målet för inklusion
bör nås under 2015 och den första rapporten kan sedan komma under 2016.
11
Introduction and Background
In a story that took place 1750 in Värmland Sweden, a farm-worker was impaled by accident on a broomstick
“in genom veka lifvet til tarmarna” (through the abdominal wall and into the intestines) resulting in a
spontaneous stoma. The man used a homemade leather bag as a stoma dressing. The story ends with “
Drängen är nu för öfrigt aldeles frisk, och kan göra hvarjehanda bondearbeten.” (the farm-worker is now
perfectly healthy and can perform all sorts of work on the farm). This description can be found in the
archives of the Royal Swedish Academy of Sciences1.
This story is one of several descriptions of spontaneous stoma-formation after an accident, or as a fistula
after incarcerated hernia2,3. Littré was probably the first to propose a stoma as part of treatment for
imperforate anus in infants in 1710, but the very first description of stoma-surgey was of an operation
performed in 1793 by Duret on a child with anal atresia2. The first stages in the history of surgery were
surrounded by risk. Mortality and morbidity rate were high, and just surviving was an enormous success. In
Copy with permission from the
Royal Swedish Academy of
Sciences. Author: Johan Hesselius
in the year 1750.
12
the beginning of the surgical era it was most important task to perform surgery quickly since anaesthesia was
not an option. Courageousness, and maybe madness, was probably necessary as well.
Over the last century, considerable progress has been made. Anaesthesiology has made it possible to perform
major surgery. Antibiotics and our knowledge of bacteria and antiseptics has significantly reduced
postoperative mortality and morbidity. Surgery has been refined with the development of minimally invasive
techniques and laparoscopy. Medical equipment is constantly being improved, and materials used for
different kinds of implants, such as hernia mesh, are continually being invented and improved.
The description from Värmland 1750 above describes a man who survived an accident with an expected
mortality close to 100%. He was lucky; the stoma-formation probably saved his life by preventing peritonitis.
Even today stoma-formation can save lives, especially in emergency situations with faecal peritonitis and/or
intestinal obstruction. There are many reasons for stoma-surgerys; cancer, Crohns disease, ulcerative colitis,
diverticulitis, urinary disorders and faecal incontinence to name but some. The total number of new stomas
each year in the county of Norrbotten in Sweden is approximately 130. Extrapolating from this figure the
number of new stomas in the whole of Sweden exceeds 4500 procedures each year.
Rectal cancer is common, and in Sweden approximately 2000 patients are diagnosed each year4. More than
one third of these patients will have a permanent stoma after their operation. Sweden seems to have a higher
proportion of permanent stomas after rectal cancer surgery compared to countries in southern Europa. The
use of very low anastomoses is probably more common in these countries, though the reason for this is not
fully understood, but social and emotional factors probably play an important role. Even within Sweden there
are differences, with a higher proportion of permanent stomas in the northern compared to the southern
part4.
A stoma requires appropriate stoma dressing and a proper placement on the abdominal wall if it is be
handled easily. Leakage and fear for leakage causes the patient considerable inconvenience and
embarrassment. Bad placement of the stoma will result in problems in changing dressings and trouble with
clothes5. The farm worker in 1750, with the stoma located at the site of the injury, arranged his stoma
dressing with a leather bag. The story does not tell whether or not its location on the abdominal wall was
optimal, but on the other hand, he had no choice.
The side-effects of a stoma include the risk of developing a parastomal hernia which might cause additional
problems with dressing and clothing as well as the risk for incarceration6,7. There is no standard definition of
a parastomal hernia. In some studies it is defined as a palpable bulge around the stoma during a Valsalva
maneuver8 whereas in other studies no definition is given9. Another definition of parastomal hernia is
protrusion of a peritoneal sack beside the stoma10. The sack may contain a part of the bowel other than the
stoma segment, or other intra-abdominal content. The incidence of parastomal hernia varies in studies from
a few percent up to 78%11,12. If one assumes the true figure to be 50%, more than 2000 patients in Sweden
will develop a parastomal hernia each year.
Quality-of-life (QoL) has become more important as an endpoint after surgery since survival after cancer has
improved as a result of chemotherapy and radiotherapy together with refined surgery and anaesthesia.
Patients expect a good QoL after surgery and we must develop ways of assessing the patient´s own
experience. The farm worker in 1750 was perfectly healthy and could perform all sorts of work on the farm
after his accident. It be that quality of life is judged differently nowadays, but to be able to perform MANY
activities after surgery is a high goal even today. Efforts aimed at giving patients the best possible QoL are
essential and should be given high priority.
This thesis focuses on patients with stoma and parastomal hernia. The incidence is still a matter of debate as
it is difficult to make the diagnosis. A bulge around the stoma is not always a hernia and should probably not
be treated as such. New diagnostic tools improve diagnostic accuracy. Several treatment options are
available, but at yet none has been shown to be superior. Is implantation of a mesh the solution? Finally, in
our efforts to attain a better outcome, the patient’s experience of HRQoL is important, and this aspect
requires more investigation.
13
Investigation
The human body may be examined in various ways. Our senses have been used throughout the history.
Manual examination, palpation, is still very important. A change in status can often be revealed by repeated
palpation over a short or long period of time. Auscultation can detect a pneumonia or heart disease. General
inspection often gives a good picture of the patient´s general condition. In former times doctors even used
their sense of taste to diagnose diabetes mellitus by the sweet taste of urine.
Radiology, laboratory tests and other techniques have evolved over the last century. It is now possible to
store, confirm and reproduce findings in large populations thanks to computers.
Investigation of stoma complaints can be done by inspection of the stoma. Location of the stoma is important
for easy dressing. A bulge around or above the stoma may cause considerable disability. Iirritation, or even
ulcerations, of the skin around the stoma may be a sign of inappropriate stoma appliances5,13.
Palpation is essential when examining a stoma. Difficulties in evacuation can be caused by a tight stoma
orifice or dislocation between the fascia and muscle layers causing a valve effect. Bulging and parastomal
herniation often leads to problems with leakage and stoma dressing14-16. It also affects body image and fitting
of clothes. Incarceration and the need for emergency surgical intervention can occur in the event of
herniation17,18.
To clinically distinguish between a bulge and a hernia is difficult19. A possible cause of bulge can be
denervation of parts of the abdominal wall when constructing the stoma, or after other abdominal
procedures. The bulge can also be caused by a part of the stoma segment protruding, or telescoping, through
the abdominal wall. A hernia can involve a part of the intestine other than the stoma segment - fatty tissue,
part of the omentum or other intra-abdominal content - herniating alongside the stoma. The European
Hernia Society´s (EHS) classification of parastomal hernias is a helpful when clinically assessing a
parastomal hernia20. This classification divide parastomal hernias into four groups; I and II up to 5 cm with
or without concomitant incisional hernia (cIH), respectively whereas III and IV more than 5 cm with or
without cIH. A radiological classification of parastomal hernia, based on CT-scan, divides the
bulging/hernias into five groups: 0 – no formation of a hernia sack, I a and b - the bowel forming the stoma
with a sack smaller or larger than 5 cm respectively, II – peritoneal sack containing omentum and finally III
– an intestinal loop, not the stoma segment in the sack, where class I b, II and III are regarded as parastomal
hernia10. Class I a describes a protruding/telescoping part of the bowel segment forming the stoma. Palpation
alone is not sufficient to differentiate between a bulge, a protrusion and a parastomal hernia19.
Computed tomography (CT) can be a helpful tool when examining patients. Studies have shown the
incidence of parastomal hernia to range between a few percent and 78% when combining CT and clinical
examination11,12. A Kappa index value of 0.4, when comparing diagnostics of parastomal hernia by CT scan
and clinical assessment, illustrate the diagnostic difficulties10. CT may underestimate clinical findings as
shown by Emanuelson et al21. A negative aspect of CT is exposure to radiation. CT in the prone position might
provide a more accurate information22 especially using the Valsalva manoeuver. However, in clinical practice
CT is performed in the supine position without a Valsalva manoeuver. The clinical significance of a
subclinical hernia, detected by CT, is not clear. On the other hand, the ability to distinguish a hernia from a
bulge or protrusion is very helpful when making decisions about treatment.
Ultrasonography does not expose the patient to radiation. Ordinary two-dimensional ultrasound is
dependent on the examiner. Second opinion of the images is often not possible. Three-dimensional
ultrasonography has been developed for endoanal and endorectal examinations. In the rectum, adenomas
can be examined and the depth of tumour growth can be measured, making it possible to stage the
14
tumour23,24. Endoanal ultrasonography is a good diagnostic tool for perianal fistulae and abscesses25,26. An
advantage is the possibility to get a second opinion of the images. Three-dimensional intrastomal
ultrasonography (3D US) is a novel development of this technique providing the possibility to examine
parastomal complaints including the possibility and to revise interpretation27,28.
3D examination in erect position.
Subcutaneous tissue
Fascia
Muscle layer
Normal 3D US image with the probe in
the stoma.
15
However, this novel technique has to be scientifically evaluated. CT, on the other is hand, is an established
imaging technique and today a routine investigation.
Two papers in this thesis evaluate the validity and reliability of 3D US as an alternative to CT for the
assessment of parastomal complaints including evaluation of inter- and intra-observer evaluation.
Surgical treatment
The word stoma means mouth or opening, and natural stomas are, for example, the mouth and the anus.
Artificial intestinal stomas include an opening through the fascia and muscles of the abdominal wall. This
causes a weakening and thus possible locus for herniation29.
Operations that include ileo-colic, colic-colic, colo-rectal or other anastomoses are at risk for healing
disturbances, resulting in anastomotic leakage. Reasons for this include infection or poor perfusion. In such
circumstances, stoma deviation may be necessary. In other cases a stoma is required after resection of a very
low rectal cancer where anastomosis is not possible, or as part of palliative treatment.
A stoma may be permanent or temporary. Hartmann´s procedure (HA) (resection of the sigmoid colon,
blind closure of the distal bowel and an end-colostomy of the proximal bowel segment) is often planned with
a temporary stoma, but up to 40-50% eventually become permanent30. When HA is performed for low rectal
cancer, the stoma is permanent. Loop-stomas are mostly planned as temporary, but occasionally they are not
reversed and end up as permanent stomas. Between 25 and 40% of transverse loop colostomies are not
reversed18.
Meticulous surgical technique and precision is important when creating a stoma17. Stoma formation is often
undertaken at the end of a long operation to quote Shellito “there is a tendency at that point to rush the
process or leave it to a junior member of the surgical team”18. After radically resecting cancer, the patient’s
life may be saved, but a poorly constructed stoma can make a major difference to the patient’s QoL.
Poor stoma positioning can result in difficulties with stoma dressing, in term of both fitting and function5,31.
Leakage of faeces with soiling of clothes is not only embarrassing but can also cause irritation and even
3D US image, modulated in render-
mode. A parastomal hernia can be
seen.
Parastomal hernia
16
ulceration of the skin surrounding32. Special stomal barriers and frequent visits to the stoma nurse may be
necessary. From an economical point of view, a stoma that requires special dressings and barriers is
expensive and the cost for the community can be three times that of a well-functioning stoma13. Patients may
need to take time off work to visit the stoma nurse, affecting the patient’s economic situation16.
Not paying attention to the perfusion of the bowel when forming the stoma may result in ischaemia and
necrosis requiring emergency intervention17. Ischaemia, not requiring acute surgery may result in subsequent
stoma stenosis18. Other complications of stoma formation are prolapse of the stoma and peristomal fistula.
Patients with underlying disease, such as Crohn´s, are more likely to develop both fistulae33 and stenosis.
Parastomal herniation is a common complication to stomas; by some authors even claimed as not
avoidable34. Incidence figures range from a few percent up to 78%, but due to the difficulties of diagnosing
these figures must be considered difficult to interpret11. Asymptomatic hernias are common. A not negligible
proportion of patients have discomfort and complaints from a bulging stoma6. Parastomal hernia can
develop up to 20 years after the index operation, although in most cases much earlier7,35.
Occurrence of parastomal hernia is probably influenced both by habitual and technical factors. Malnutrition,
obesity, elevated intra-abdominal pressure and immunosuppressive drugs such as corticosteroids are all
likely to increase the risk for developing both incisional and parastomal hernias, though there is no stronger
scientific evidence than the opinion of authors11. Surgically, technical factors proposed to influence on
parastomal herniation include; size of trephine hole in the abdominal wall; closure of the lateral space;
fixation to the fascia; location of the opening through the rectus muscle and the use of intraperitoneal or
extraperitoneal technique. Contact with a stoma therapist has also been proposed having influence.
There is no robust evidence in support of stoma passage through or lateral to the rectus muscle to reduce the
rate of parastomal herniation36. Size of the opening in the abdominal wall has been much debated, and a
trephine allowing one or two fingers to pass is usually suggested11, despite the fact that finger size varies.
Some recommendations of the size of the aperture in centimeters have been made37,38 and specially designed
devices to enable a reproducible aperture have been designed39,40. There are reports showing that larger
apertures are associated with a higher incidence of parastomal hernia41. However, the aperture need
probably not be wider than that necessary to allow the bowel to pass without causing perfusion
embarresment.
Extraperitoneal techniques have been suggested to reduce the risk for parastomal hernia formation. Studies
comparing transperitoneal and extraperitoneal end colostomy formation have reported a lower parastomal
hernia rate with the extraperitoneal route11,42. However, only one of five studies showed a statistically
significant difference7. None of these studies was randomised or controlled.
Stomal necrosis
17
Fixation of the bowel to the fascia or abdominal wall has not been shown to prevent hernia formation11. An
acute surgical intervention that includes a stoma has been proposed as a factor contributing to hernia
formation. A retrospective study, however, could not show any difference between the elective and
emergency setting43. The employment of a stoma therapist in choosing a suitable location for the stoma on
the abdominal wall may play an important role16, though this has not been confirmed44.
There have been a few small studies on the use of prophylactic mesh reinforcement at the primary stoma
operation to reduce the rate of parastomal hernia formation. Mesh material varied between the studies as
well as the placement of the mesh – onlay, sublay or intraperitoneal42. A meta-analysis including three,
though small, randomised controlled studies, including in all 128 patients, showed promising results with a
hernia rate of 12.5% in the mesh group compared to 53% in the control group45. In contrast a retrospective
study from Västerås, Sweden, showed no change in parastomal hernia rate (23%) before and after the
introduction of prophylactic mesh in routine practice46.
There are several ways of treating parastomal hernia, but the results are usually disappointing. Local tissue
repair represents s convenient way to reduce and treat a hernia. The stoma can be maintained in its position
and laparotomy can be avoided. The recurrence rate, however, is disheartening, ranging from 48.4 to 66.4%
according to data published in a meta-analysis47. Postoperative complications were reported in 14.1% of the
patients in the same meta-analysis. One study compared local tissue repair with stoma relocation, revealing
recurrence rates of 76% and 33% respectively48.
Stoma relocation is sometimes needed due to unsatisfactory placement at the index operation, resulting in
leakage and problems with stoma dressing. In eight small studies, including only 91 patients11, stoma
relocation to treat parastomal hernia, had a reported recurrence rate a ranging from 0 to 76.2%. It may be
that a new location on the contralateral side of the abdominal wall can give a lower recurrence rate49, but the
collagen characteristics are still the same.
Mesh is an established method to treat inguinal as well as incisional hernia. In 1977, an early report described
polypropylene mesh, applied as a fascial on-lay prosthesis, to be an option in parastomal hernia repair50.
Since then, several studies have described mesh in the sub-lay and intraperitonal on-lay (IPOM) positions in
parastomal hernia repair42. In a meta-analysis, on-lay mesh repair was shown to have a recurrence rate of
14.8% (median follow-up 40 months) and a complication rate of 11.1% 47. Mesh in the sublay position had a
recurrence rate of 7.9%, and a total complication rate of 14.5%, but the median follow-up time was short; 24
months with a range of 12-32 months47.
The IPOM technique is often used laparoscopically when repairing incisional hernia. Meshes designed for
parastomal hernias can be used both in open and laparoscopic surgery. The meshes are often of the
composite type consisting of one non-adhering material facing the bowel, and one adhering material towards
the abdominal wall. The stoma bowel is passed through an aperture in the mesh – “key-hole” – or lateral to
and between the mesh and the abdominal wall – the “Sugarbaker´s method”51. There are small studies
comparing the Sugarbaker and key-hole techniques performed laparoscopically, with a slightly lower
recurrence rates for Sugarbaker (Sugarbaker 11.6% and key-hole 20.8%), though the follow-up time was
relatively short; 24-36 months52. A combination of both Sugarbaker and key-hole – the sandwich technique –
has a reported hernia recurrence rate of 2.1% in one single-centre study, after a median follow-up of 20
months53.
Mesh material has varied between the studies and including: polytertrafluoroethylen (ePTFE),
polypropylene, biological implants and various composite meshes. The studies have been small and there is
no strong evidence supporting one technique in over another. New materials must be evaluated and the
safety profile is of paramount importance.
One paper in this thesis reports a prospective study evaluating safety and the recurrence rate using an IPOM
specially designed for the repair of parastomal hernia.
18
Quality of life
The farm-worker in Värmland could do all sorts of work and was in good health after his accident. His QoL is
described in a few words, but what he actually experienced cannot be interpreted from this story. QoL is a
personal experience, nevertheless it is important to assess how the patient experiences daily life and health.
Legislation on patient involvement in their own healthcare has also made health-related QoL (HRQoL) an
important ednpoint. Studies have shown that QoL assessment leads to more patient involvement in surgical
treatment decisions54. Good QoL is not always equivalent with a perfect health. There is a saying “it is not
how are, but how you feel” impying that even though a person has a serious or severe medical condition his
perceived QoL can be very good. In 1948 the World Health Organisation (WHO) stated health as being “the
state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity”55.
Many factors, social, emotional, physical, religious just to name a few, play an important role in a person’s
life. The WHO defines QoL as “individuals´ perception of their position in life in the context of the culture
and value system in which they live and in relation to their goals, expectations, standards and concerns”56.
Morbidity and mortality are important outcome measurements in medical care, but over recent decades
there has been a rise in interest in measuring and assessing health beyond these traditional indicators.
Several tools to measure the impact of disease and impairment on daily life have been developed and
validated. There is a lack of solid criteria on how to construct and validate health scales57. Validations of QoL
module tests among patients have been performed on several occasions. Test-retest reliability can be
obtained by a group of patients answering the test questionnaires two or three times58. Focus groups can be
used to obtain relevant questions59.
Patient interviews, often used in qualitative research, can add in-depth information of the perceived QoL and
provide additional information. This methodology focuses on smaller samples, often strategically chosen, in
contrast QoL questionnaires that are used for larger populations.
There are tools focusing on overall QoL and other more disease-specific tools. The overall QoL tools cover
topics of physical, psychological and social function, wellbeing and physical symptoms. Disease-specific tools
Ice-covered Luleå river 15th of March
2015.
19
focus on aspects of the disease and the treatment that may affect QoL. These tools often complement each
other, providing additional information about the patient’s situation and perceived QoL60.
Living with a stoma can evoke both anxiety and embarrassment, leading to changes in life quality61. Surgical
technique and placement of the stoma not too near the belt level or the waistband line were obviously
important, but patients successively adapt to the change in situation5,15,62. Leakage and difficulties in
applying and keeping stoma bags in place are reported to reduce QoL5 as do bulging and parastomal hernia6.
In the fourth paper in this thesis, patients operated for rectal-cancer answered four different HRQoL
questionnaires, providing information about their perception of living with or without a stoma. Special focus
was placed on the influence of a bulge or a parastomal hernia on QoL.
20
List of Publications
Strigård K, Gurmu A, Näsvall P, Påhlman L, Gunnarsson U.
Intrastomal 3D ultrasound; an inter- and intra-observer evaluation.
Int J Colorectal Dis 2013; 28: 43-47
Näsvall P, Wikner F, Gunnarsson U, Rutegård J, Strigård K.
A comparison between intrastomal 3D ultrasonography, CT scanning and findings at surgery in patients with
stomal complaints.
Int J Colorectal Dis 2014; 29: 1263-1266
Näsvall P, Rutegård J, Dahlberg M, Gunnarsson U, Strigård K.
Parastomal hernia repair with intraperitoneal mesh.
Submitted
Näsvall P, Rutegård J, Dahlstrand U, Löwenmark T, Gunnarsson U, Strigård K.
Quality of life with permanent stoma after rectal cancer surgery
Manuscript
21
Aims of this Thesis
Parastomal hernia is difficult to diagnose and the treatment options are numerous. No repair technique has
shown to be superior. Patient experience is of paramount importance if we are to be able to offer the best
possible treatment. This thesis focuses on three aspects of parastomal hernia;
the development of accurate diagnostic tools, enabling correct surgical decisions
the treatment of diagnosed parastomal hernia
the patient´s own experience of living with a stoma and its impact on daily life, with particular
emphasis on bulging and parastomal hernia
Paper I
To determine the inter- and intraobserver reliability of three-dimensional ultrasonography imaging in the
diagnosis parastomal hernia.
Paper II
To assess the validity of intrastomal three-dimensional ultrasonography as an alternative to computed
tomography for the assessment of stoma complaints
Paper III
To evaluate the safety and recurrence rate of parastomal hernia repair using a Parastomal Hernia Patch
BARDTM.
Paper IV
To evaluate the quality of life of patients living with a permanent stoma after rectal-cancer surgery, and the
prevalence and effect of parastomal hernia or bulging on QoL.
22
Patients and Methods
Studies I and II
3D US - three-dimensional intrastomal ultrasonography
3D US is a technique producing images which can be rotated and scrolled in different projections during
interpretation. The possibility of saving images and sending them to another investigator enables second
opinion. The images can be remodulated in render mode (computer-aided reconstruction of the images)
which provides better visualisation of structures by augmenting some and diminishing others63,64. The
investigation can be performed at the time of clinical examination, and the patient can be examined in both
the supine and erect position. The clinical investigation and imaging technique can thereby complement one
another. If the patient has stoma complaints in a specific position or during straining, the ultrasound-
examination can be performed in that specific situation. Study I focus on the reliability, and Study II on the
validity of 3D US.
Study I
Patients seeking healthcare due to stoma complaints i.e. bulging, suspected hernia, leakage, pain or other
stoma-related problems, were invited and signed informed consent obtained. Patients were recruited from
three hospitals; Sunderby Hospital, Karolinska University Hospital and Norrlands University Hospital, and
all, but a few with an ileostomy, had a colostomy.
According to the study protocol, patients were divided into a baseline group of twenty patients, and groups of
ten thereafter. Two or three physicians examined all patients clinically. 3D US performed by one of the
clinicians with the patient in both supine and erect positions, with and without a Valsalva manoeuver. The
images were transferred to USB memory sticks and interpreted by each physician separately. A protocol was
followed and each one of the examiners personally completed separate protocol-forms, both for the clinical
examination and 3D US investigation (Figure 1). Assessments according to the protocol were made after each
examination sequence, and a second assessment of the 3D US protocol was made one month later. Before the
second assessment, the first protocol was sent to a study nurse as to avoid bias at the second 3D US
assessment.
In the protocol differentiation between a bulge, a protrusion and a hernia was made. Hernia was defined as a
peritoneal sack protruding through a fascial defect beside the stoma-bowel. Any content in the hernia sack
was described as bowel, omentum or other. Protrusion was defined as subcutaneous excess of bowel forming
the stoma with no fascial defect. A bulge was what that seen clinically with the patient usually in erect
position. The reason for a bulge could be a hernia, protrusion or a bulging of the abdominal wall without
hernia or protrusion.
The physicians in this study had different degrees of experience in endoanal and endorectal 3D ÙS
examination, one with extensive experience and the other two with short period of previous training. The
ultrasound machine used was Profocus 2202 (BK Medical, Herlev, Denmark) with a 2050 transducer. The
transducer, fitted for enodanal and endorectal 3D US examinations, was covered with a water-filled balloon
and taped individually to fit the subcutaneous fatty tissue of each patient27. Normally 30-40 ml of water was
needed to fill the balloon, and the rectal setting with 9 MHz was used for the probe.
23
Statistical analyses were performed using Fleiss´ kappa, calculating inter-rater reliability with more than two
observers. Table 1 shows interpretation of the Fleiss´ kappa values. Congruence between investigators was
calculated as the proportion of unanimous assessments.
Figure 1 Protocol used for clinical and 3D US evaluation.
Table 1 Fleiss´kappa value and the interpretation of level of
agreement
< 0 Poor agreement
0.01 – 0.20 Slight agreement
0.21 – 0.40 Fair agreement
0.41 – 0.60 Moderate agreement
0.61 – 0.80 Substantial agreement
0.81 – 1.00 Almost perfect agreement
Investigator Patient name
Clinical investigation
Inspection; Erect bulge □ no bulge □
Position 9-12 □ 12-3 □ 3-6 □ 6-9 □
Supine bulge □ no bulge □
Position 9-12 □ 12-3 □ 3-6 □ 6-9 □
Palpation Normal □
Weakness □
Position 9-12 □ 12-3 □ 3-6 □ 6-9 □
Protrusion □
Hernia □
Position 9-12 □ 12-3 □ 3-6 □ 6-9 □
Ultrasound Normal □
Protrusion □
Hernia □
Position 9-12 □ 12-3 □ 3-6 □ 6-9 □
Intestine yes □ no □
Fascia circ. □ partial □ no ass. □
Rectus circ. □ partial □ no ass. □
Mesh no □ onlay □ sublay □
Comments □…………………......................
24
Study II
Twenty patients with stoma-related symptoms - hernia, protrusion, fistula related to implanted mesh - to
such a degree that surgery was judged necessary were enrolled into the study. Three hospitals recruited
patients; Sunderby hospital, Umeå University hospital and Karolinska University hospital Huddinge.
Preoperative assessment including CT of the abdomen, 3D US and clinical examination was performed.
Intraoperative findings, seen as the true outcome, were compared to findings at CT and 3D US. Three
investigators experienced in endoanal and endorectal ultrasonography performed the 3D US examination,
and two investigators blinded to the other interpretation evaluated all 3D US images. The ultrasound
machine was the same brand as in Study I and the technique described in a study by Gurmu et al27.
CT examinations were performed at the radiology department of each hospital participating, with the patient
in the supine position. Twice two radiologists blinded to each other’s evaluation interpreted the images, first
as a routine evaluation by an experienced radiologist and then a second time by a dedicated radiologist.
Surgery was performed at each hospital by experienced colorectal surgeons. All had a special interest in
stoma complaints and hernia. Findings at surgery were registered for later comparison with findings at the
preoperative assessment.
Statistical analyses for sensitivity, specificity, positive likelihood ratio (LR+), negative (NPV) and positive
predictive value (PPV) were planned using cross-tables in IBM SPSS Statistics 22 software packages.
Study III
Fifty consecutive patients seeking medical care due to parastomal hernia and symptoms related to the hernia
requiring surgery were invited to take part in the study. Symptoms included leakage, problems with stoma
dressings, bulging and signs of incarceration. Patients who did not agree to participation in the study was
offered surgery according to each department´s routine; stoma-relocation, narrowing of the stoma aperture,
or implant of a mesh in a sub-lay position. Demographic patient-related data including gender, body mass
index (BMI), ASA, presence of incisional hernia, peroperative blood loss, and type of stoma were recorded.
Preoperative assessment included CT of the abdomen in the supine position at each hospital´s radiology
department. The images were interpreted as a routine investigation by experienced radiologists. Repair was
performed using an intraperitoneal on-lay mesh (IPOM) technique with Parastomal Hernia Patch BRADTM
(PHP), specially designed mesh for parastomal hernia. This mesh consists of two layers; one of
polypropylene which is placed facing the abdominal wall to allow ingrowth and adherence to the peritoneum,
the other of polytetrafluoroethylene (ePTFE) with the property not adhere to the bowel or other intra-
abdominal content, and thus placed facing the bowel. The mesh is oval shaped with a key-hole aperture
allowing the intestine forming the stoma to pass through, and there are four ePTFE flaps around the hole by
which the intestine may be anchored, each with one suture (Figure 2). It is manufactured in two sizes; 12.5 x
15.5 cm and 15.5 x 20.5 cm.
25
After repositioning the content in the hernia and measuring the size of the hernia opening, the PHP was
placed with overlapping of the key-hole opening lateral to the stoma bowel. The mesh was tacked in place
through slits in the ePTFE-layer.
The operations were performed at the four participating hospitals by surgeons with good experience of using
the PHP. After postoperative mobilisation according to each hospital´s routine, patients were followed up at
one month and one year postoperatively. Clinical assessment for early complication at one month and
possible recurrence of parastomal hernia and late complications at one year was performed. CT was also
performed at one year.
Statistical analyses regarding hernia recurrence rate, early and late complications were performed using IBM
SPSS Statistics 22 software packages.
Study IV
There are several HRQoL forms available and in this study four different ones were used: the EORTC QLQ-
C30, the EORTC QLQ-C38, the SF-36 and the Stoma Questionnaire (SQ). Both the EORTC QLQ and SF-36
forms require a license for use, and these were obtained.
The European Organisation for Research and Treatment of Cancer (EORTC) is a non-profit organisation that
was started over 30 years ago by a group of experts interested in the field of QoL. Their aim was to develop
tools for measuring QoL in cancer trials. So far the EORTC has validated numerous HRQoL modules specific
for different cancer diagnoses, colorectal cancer being one of these58,65. The EORTC QLQ-C38 is a specific
module for used in colorectal cancer surveys66. The modules are translated into several languages, including
Swedish. It comprises 38 items grouped according to: a. function - body image (BI), future perspectives (FP),
sexual functioning (SX) and sexual enjoyment (SE): – and b. symptom – micturing problems (MI),
gastrointestinal symptoms (GI), chemotherapy side-effects (CT), defaecation problems (DF), stoma-related
problems (STO),weight loss (WL), male (MSX) and female (FSX) sexual problems. Each item is rated on a
scale by the patient.
PTFE flaps
Key-hole opening
ePTFE-layer to face the
bowel
Figure 2. Picture of the Parastomal
Hernia Patch BARDTM
26
The EORTC QLQ-C30 module must be used in conjunction with the EORTC QLQ-C38. The QLQ-C30
module is a general QoL questionnaire designed for cancer patients65,67. It comprises 30 questions covering
general well-being and is divided into: a. function groups (physical function (PF), role function (RF),
cognitive function (CF), emotional function (EF) and social function (SF)) b. symptom groups (fatigue (FA),
pain (PA), nausea and vomiting (NV)) and six single-item questions concerning dyspnoea (DY), insomnia
(SL), loss of appetite (AP), constipation (CO), diarrhoea (DI) and financial impact (FI). Global health status
is measured by combining the last two questions in the questionnaire.
The EORTC questionnaires were analysed according to the manual68 and the answers to the questions were
rescaled from 1 to 100. High scores in function and global QoL indicate healthy or high function level and
high QoL. In the symptom and the single item questions a high score indicates many symptoms.
The Medical Outcome Trust (MOT) started in 1992, and has been affiliate of the Health Assessment Lab
(HAL) since 2008 and is based in Boston, USA. It is a non-profit organisation aimed at improving healthcare
through promoting research on outcome measures. The Short Form 36 (SF-36) is a validated QoL
instrument translated into Swedish and produced by the MOT57,69. It comprises of 36 questions concerning:
physical functioning (PF), physical role functioning (PRF), bodily pain (BP), vitality (V), general health
(Gen), social functioning (SF), emotional role functioning (ERF), mental health (MH), physical component
summary (pcs) and mental component summary (mcs).
Software for the rescaling and scoring of data from the SF-36 comes together with the license agreement.
Rescaling converts the scores to a scale 1-100, were 100 indicates best possible health or no disability.
The SQ is a validated 15-item questionnaire designed for stoma-patients19. It focuses on how the stoma
affects the patients’ daily activities, sexuality, body appearance and any limitations to daily life.
Available data from Swedish “normal population” were used for comparison with both the SF-36 and EORTC
QLQ-C30 67,70,71. Comparisons of the data were performed by comparing mean values between groups using
Student´s independent t-test, p-values < 0.05 were considered significant. All analyses were performed with
IBM SPSS Statistics 22 software package.
Patients included in the study were identified in the SRCR. They were operated with resection surgery and
permanent colostomy (APR and HA) for rectal cancer between 1996 and 2004 in the Uppsala/Örebro,
Stockholm/Gotland and Northern Regions in Sweden. Patients operated in the Karolinska University Solna
and Sundsvall hospitals were excluded, since they had already adopted the use of prophylactic mesh around
the stoma. A control cohort of 275 patients operated with AR without permanent stoma in the Northern
Region was used as a control. In this group 57 (21%) still had a diverting loop-ileostomy in 2008 and were
thus regarded as having permanent stomas.
The HRQoL forms, with a stamped addressed envelope, were sent by mail to 986 patients (768 with and 218
without a permanent stoma) via the Mailit company. One reminder was sent to those not responding.
27
Results
Study I
Forty patients were included in the study, twenty in the base-line group and ten in each of two subsequent
groups. 3D US-images from the baseline group were assessed by all three investigators, and from the
following two groups by two investigators. A stepwise improvement in inter-observer agreement was
observed; from 70% in the baseline group, to 80% in the second group of ten patients. The Fleiss´kappa
value was 0.41 for the first twenty patients reaching 0.7 in the last ten, with a mean of 0.59 for the entire
cohort.
Intra-observer agreement was calculated for the most experienced and one for the other two investigators.
Despite the shorter training period for one investigator, the intra-observer agreement increased from
moderate to substantial. Intra-observer agreement also increased between each additional group. After 30
patients, reliability had reached “good” and “excellent” respectively. Results from the last ten patients
revealed that the learning curve levelled out at 30 patients (Table 2).
Table 2
Patient number
1-20 21-30 31-40 Total
Inter-observerreliability
Fless`kappa 0.41 0.55 0.70 0.59
Agreement 70% 70% 80% 72.5%
Intra-observer
reliability
Observer 1 Fleiss`kappa 0.66 1.0 0.76 0.79
Agreement 80% 100% 90% 93%
Observer 2 Fleiss´kappa 0.19 0.53 1.0 0.39
Agreement 70% 70% 100% 80%
28
Study II
Eight men and 12 women were included in the study. Table 3 shows demographic data. Findings at surgery
revealed 18 cases with a parastomal hernia. The other two patients were shown to have fistulae related to a
mesh implanted around the stoma. The fistulae had been detected at the preoperative 3D US examination.
Two of the 18 patients with a parastomal hernia had previously had a mesh implanted around the stoma. All
four previously implanted meshes were removed at surgery.
Nineteen patients were operated with a mesh; 17 applied as IPOM, one stoma-relocation in combination with
IPOM, and one with a mesh in the sub-lay position. The twentieth patient had the stoma moved without a
mesh.
The results of comparison between findings at surgery and those at the preoperative assessments (CT and 3D
US) are shown in Table 4. The sensitivities when comparing CTs evaluated the second time by a dedicated
radiologist, and 3D US, with findings at surgery were both 15/18 (83%). CTs evaluated in the routine setting
showed a sensitivity of 17/18 (94%). Specificity for both routine and dedicated CT evaluations was 1/2 and for
3D US 2/2. Positive predictive value (PPV) was 15/15 for 3D US, 17/18 for routine CT and 16/17 in the
dedicated CT evaluation. Negative predictive value (NPV) was 2/5 for 3D US, 1/2 for routine CT and 1/4 for
the dedicated CT evaluation. The positive likelihood ratio (LR+) value was 1.88 for the routine and 1.66
second for the dedicated CT evaluation of CT. LR+ was infinite for 3D US.
Table 3 Demographic data
Gender
Female/male 12/8
Age (years)
Median (range) 67 (19-91)
BMI
Median (range) 26 (19-35)
Reason for
stoma
Cancer 12
Diverticulitis 1
IBD 4
Other 3
29
Table 4 Cross-table comparing findings at surgery with the preoperative assessments.
Findings at surgery
Findings at 3D US interpretation No hernia Hernia
No hernia 2 3 5
Hernia 0 15 15
2 18 20
Findings at routine interpretation of CT
No hernia 1 1 2
Hernia 1 17 18
2 18 20
Findings at dedicated interpretation of CT
No hernia 1 3 4
Hernia 1 15 16
2 18 20
Study III
Fifty patients were enrolled in this study and demographic data are shown in Table 5. All patients were
operated with PHP in an elective setting. Means for operating time, blood loss and length of postoperative
stay are shown in Table 5. The smaller mesh was used in 35 patients whereas the remaining 15 cases were
reconstructed using the larger mesh.
The complication rate at one-month follow up was 16/50 (32%), all but one (pneumonia in conjunction with
a urinary tract infection) were considered surgical complications; six wound infections, five deep infections,
one stoma prolapse and three with postoperative intestinal obstruction. One of the deep infections proved to
be caused by leakage from the small intestine. At the one-month follow-up, seven (14%) patients had been
reoperated; two cases due to incarcerated recurrent parastomal hernia, and one, as mentioned above, due to
leakage of the small intestine (Table 6).
The clinically identified parastomal hernia recurrence rate at one-year follow-up was 11/50 (22%), and 17/50
had parastomal bulging. Due to meshes having been removed at reoperation already within one month, three
patients were censored and not followed up with CT at one year. Of the 47 patients examined with CT, a
recurrent parastomal hernia was found in 7/47 (15%); parts of the bowel other than the stoma segment was
found in the hernia in six patients, and omentum in the seventh. In eight patients, a stoma segment
protruding subcutaneously in the abdominal wall was seen on CT. A further five patients had been
reoperated by the one-year follow-up due to recurrent parastomal hernia, obstruction of small intestine,
incarcerated parastomal hernia, and ventral hernia (not related to the stoma). A total of 12/50 (24%) were
reoperated within one year after surgery (Table 6).
30
Table 5 Demographic and perioperative data
Patient gender Male/Female 27/23
Age (year) Median (range) 72 (23-93)
BMI Median (range) 27 (15-38)
ASA ASA 1 2
ASA 2 30
ASA 3 17
ASA 4 1
Smoking habits Smoker/Non-smoker 3/47
Type of stoma Colostomy 33
Ileostomy 8
Urostomy 9
Operating time (min) Mean (range) 110 (40-
377)
Blood loss (ml) Mean (range) 66 (0-750)
Postoperative stay (days) Median (range) 4 (1-22)
31
Table 6 Postoperative complications
Postoperative complication at one
month 16 (32%) Pneumonia and urinary tract infection 1
Wound infection 6
Deep infection 5
Postoperative intestinal obstruction 3
Prolapse of the stoma 1
Reoperation at one month 7 (14%) Mesh removed due to infection 2
Small bowel leakage 1
Laparotomy 3
Wound-incision due to infection 1
Reoperation at one year 5 (10%) Parastomal hernia recurrence 1
Small bowel obstruction 2
Incarcerated parastomal hernia 1
Ventral hernia (not related to the stoma) 1
Recurrence of parastomal hernia 11 (22%) Found clinically 11/50 (22%)
7 (15%) CT Found by CT 7/47 (15%)
Parastomal bulging found cliniclly 17/50 (34%)
Protrusion of stoma bowel found by CT 8/47 (17%)
n=50. CT was performed in 47/50 (three cases censored), thus n=47 regarding CT.
32
Study IV
Answers were obtained from 336 patients with and 117 without a stoma, resulting in a response rate of 46%
(453/986). Median follow-up time after rectal cancer surgery was 90.6 months (48-155) and median-age in
the responding group was 71 years (35-97). A slightly higher proportion of males (57.6%) answered the
questionnaires, which reflects the initial male/female distribution (55%/45%. Figure 3 illustrates the
distribution of responders for each QoL questionnaire.
The SF-36 and the EORTC QLQ-C30 are general QoL surveys and comparison between the groups with and
without stoma showed better mental health (MH; p=0.007), physical (PF; p=0.016) and emotional function
(EF; p=0.003) as well as slightly better global QoL (p=0.052) in the non-stoma group. The stoma group had
more pronounced fatigue (FA; p=0.019) and poor appetite (AP; p=0.027) and financial situation was to some
degree affected (FI; p=0.081). On the other hand, having an anastomosis (no stoma) gave rise to more
constipation (CO; p=0.017) and diarrhoea (DI; p=0.012).
Comparison with the “normal” Swedish population´s scores in SF-36 indicated that the non-stoma group
experienced similar QoL, except for items vitality (VT) and general health (GH), where the Swedish
background population scored higher. The stoma group scored generally lower than the “normal” population.
Both the stoma and non-stoma group had a lower QoL in the EORTC QLQ-C30 compared to the background
population.
Figure 3 Diagram showing distribution of responses for each QoL questionnaire
Although the perceived body image (BI; p<0.001) was inferior, sexual function (SX; p=0.034) was better in
the stoma group according to the EORTC QLQ-CR38. Answers to the CQ indicated negative impact on
sexuality (p=0.004) when having a parastomal bulging or hernia around the stoma, as well as impaired
psychological wellbeing (p=0.002). A hernia or a bulge around the stoma was associated with pain (p<0.001)
and fear for leakage from the stoma significantly (p<0.001) impaired the perceived function of the stoma.
Nearly one third (31.5%) of patients stated that they had a bulge or a hernia around the stoma, and almost
12% had been operated due to parastomal hernia. Stoma-related complaints forced more than 20% of the
stoma patients to seek acute medical care.
050
100150200250300350400450500
SF-36 EORTCQLQ C-30
EORTCQLQ-CR38
CQ Totalnumber of
patientsincluded
Stoma
Non-stoma
Total
33
Discussion and future aspects
Having a stoma affects QoL, and parastomal bulging or hernia further reduces the quality of daily life. Mesh
repair of parastomal hernia has the potential to be the method of choice, though with its high recurrence and
complication rate, the PHP does not seem to be optimal.
A stoma can be a saving factor in the critically ill patient, providing a temporary or definitive solution. A
stoma operation is often a planned procedure and something the patients have to live with for the rest of
their lives. Stoma complications and just adapting to the new situation affect the patient in many respects.
Care must be taken when constructing a stoma to assure good circulation and proper placement on the
abdominal wall. Parastomal hernia is a common complication where the true incidence is still a matter of
debate, reports in the literature range from a few percent up to 78%11,12. The patient experiences a bulging
around the stoma, which can complicate stoma dressings and increase the risk for leakage. A parastomal
hernia may lead to incarceration, necessitating emergency surgery. To clinically distinguish between a bulge
and a hernia is difficult19 but important as treatment of these two conditions differs.
Three-dimensional ultrasonography, an established technique in endo-anal and endo-rectal examinations,
has been further developed for examinations of stoma problms27. 3D US have been shown to provide the
ability to differentiate between a bulge and a hernia. In Study I in this thesis, the reliability of 3D US was
evaluated. The conclusion was that3D US has a reasonable learning curve and is a reliable method to
distinguish between a bulge and a hernia.
In that study, both an experienced and two less experienced investigators in assessment of endo-anal and
endo-rectal ultrasonography participated. To assess the learning curve, patients were consecutively divided
into groups; a baseline group of 20 patients followed by two groups of 10 making total of forty patients.
Doubts still exist as to whether or not the top of the learning-curve was actually reached since the inter-
observer reliability still differed between the last two groups. Kappa values may be calculated according to
Cohen, which measures nominal scale agreement between two fixed raters, or as Fleiss´, as in this study,
which measures agreement between more than two raters72. A Kappa-value of 0.7, rated as “substantial
agreement” (0.61-0.80), was reached in the last cohort, whereas the overall Kappa-value was 0.59 –
“moderate agreement”. This indicates a valid conclusion that the plateau of the learning curve had been
reached. Intra-observer agreement points in the same direction. The inclusion of both experienced and less
experienced raters in the study makes the results more trustworthy regarding generalisability.
Distinction between a hernia, a protrusion and a bulge was made when evaluating the images. The definition
of a hernia was a peritoneal sack with part of the bowel other than the stoma, or other intra-abdominal
content, such like fatty tissue or omentum, protruding out through the fascia-opening beside the stoma
(Figures 4 and 5). If excessive stoma-bowel was present in the subcutis or protruded out through the fascia
opening during Valsalva manoeuver, it was considered as a protrusion (Figures 6 and 7). A bulge, on the
other hand was an observed bulging of the abdominal wall but with no hernia or protrusion on 3D US. The
radiologic classification by Moreno-Matias et al, based on CT-scan, is quite similar73.
34
To further evaluate 3D US, a study was performed to assess its validity. In Study II the findings at 3D US and
abdominal CT were compared with each other and with the actual diagnosis made at surgery. This must be
regarded as a phase two study as only patients with pronounced symptoms requiring surgical intervention
Figure 6 Render mode 3D US image
showing protrusion of stoma bowel
Figure 7 Schematic illustration of
protrusion of stoma bowel
Muscle layer
Fascia
Skin
Figure 4 3D US image showing a
parastomal hernia
Figure 5 Schematic illustration of a
parastomal hernia
Skin
Parastomal hernia
Fascia
Parastomal hernia
Muscle layer
Stoma-bowel
35
were included making the expected rate of negative finding low. There was a high correlation between CT and
3D US findings expressed as sensitivity. The true specificity and negative predictive value, on the other hand,
cannot be established in this study due to the low rate of negative findings.
Comparison of findings by experienced radiologists and physicians performing 3D US is perhaps
questionable. All 3D US images were evaluated twice by doctors experienced in three-dimensional
ultrasonography, having performed and evaluated at least 50 3D-examinations before. In contrast to earlier
ultrasonography techniques, 3D US provides the possibility to store images for a second evaluation making it
equivalent to the CT-scan. It has been suggested that a higher sensitivity for parastomal hernia can be
achived with CT taken in the prone position22, but this technique requires a special protocol and in routine
practice CT is performed in the supine position.
Ultrasonography has the further advantage of not exposing the patient to irradiation, and 3D US is a
convenient and easily accessible method when used in direct association with the clinical examination. CT
may reveal a subclinical herniation74 that the 3D US probe might reduce. However, the use of a Valsalva
manoeuver will probably reduces that risk. On the other hand, the clinical impact of subclinical herniation is
probably not important8. To establish specificity and further evaluate 3D US, a study is planned where stoma
patients planned for abdominal surgery, with or without symptoms related to the stoma, will be included. In
conclusion, Studies I and II show 3D US to be a promising, reliable and valid tool to distinguish between a
bulge and a hernia.
As yet no technique has been shown to be superior in the treatment of parastomal hernia. The use of mesh
has been proposed as a promising option.
In Study III, a specially designed IPOM-mesh, PHP, was used treating in fifty consecutive patients being
operated for parastomal hernia. The pre-study clinical experience was good, and this was the first prospective
controlled study using this mesh. Results were disappointing with high recurrence rate, high reoperation rate
and a high complication rate. These results, however, do not differ from those most existing methods using
different forms of synthetic mesh. A known property of ePTFE is its tendency to shrink75 which may be one
explanation for parastomal hernia recurrences as the aperture of the mesh might increase. On the other
hand, shrinking could also result in a narrower aperture, which might have contributed to the complication
with strangulated bowel and subsequent leakage. There are concerns about PHP and similar prosthetic
materials, but these are still manufactured and thus this study is important. The use of ePTFE is debatedable,
but in a recent study, published in February 2015, ePTFE was used in open surgery for parastomal hernia
using the Sugarbaker technique76. This is a very small study, but it does confirm that ePTFE is still being used
for intra-abdominal implantation.
Fifty patients were consecutively recruited over a fairly long period of six years. In the first two years the
inclusion rate was higher, but then declined with time. A probable reason for this was the experience of
complications making the indication for surgery stricter as time progressed. A prospective non-randomised
study design was chosen to evaluate safety and recurrence rate, to be used as a base for future power
calculations as there was no available standard at that time. The study underlined the difficulty in
differentiating between a bulge and a hernia, with a clinical recurrence rate of 22%. Based on CT, the
recurrence rate was 15% and if a bulge was considered a hernia the corresponding rate was 34%.
With a 15% complication rate within one month, a 22% recurrence rate, and a 24% reoperation rate already
at one-year repair, PHP does not seem to be the optimal treatment for parastomal hernia. New mesh
materials are constantly being introduced. Early reports often show promising results but often with a short
follow-up time77. Hotouras et al conclude that large prospective controlled studies are required when
comparing surgical techniques78. Parastomal hernia has been described up to twenty years after the index
operation7. Biological implants are also promising, but studies have been small, often single-center, that
report favourable results 79. A problem is that these implants are expensive.
Mesh repair has become the gold standard in the treatment of incisional hernia. Aquina et al claim mesh to
be the gold standard treatment of parastomal hernias as well42. Fascia repair or relocation of the stoma
36
should be avoided due to the high recurrence rate. Mesh repair does seem to have potential to be the method
of choice. However, the most favourable placement of a mesh in the abdominal wall has yet to be determined.
Another key question is whether biological or synthetic material is the most suitable for parastomal hernia
repair. Both materials have shown promising results but biological material is very expensive. The patient´s
own tissue is another potential material that may be used. Obviously further studies in this field are required.
Good QoL is important and is a very personal experience. Tools currently available to assess HRQoL describe
what a group of patients experience and conclusions about QoL outcomes can be made on a group-basis.
However each patient is an individual and QoL depends on factors such as social, emotional, and religious
background as well as the society where he or she lives. Changes in life affect QoL and a cancer diagnosis
often changes the patient´s perspective fundamentally. If a person is cured of a potentially fatal disease he or
she might rejoice at having a new chance in life. Over time most people adapt to the new situation and
probably expect a good QoL.
After rectal cancer surgery nearly 50% of the patients4,80 end up with a permanent stoma and thus a
completely new situation in life. Stoma therapists play an important role in helping the patient to learn how
to change dressings and assist in individually fitting the stoma-dressing14. The fourth study focuses on the
HRQoL when living with a stoma after rectal cancer surgery. Earlier studies have shown QoL to be reduced in
stoma patients 16,31,81,82 with further reduction if there is a bulge or a hernia around the stoma6. The rate of
permanent stomas differs between regions in Sweden4 and some claim that patients with a stoma do not have
an inferior QoL. A Cochrane report from 2012 challenges the opinion that stoma patients have an inferior
QoL83 and calls for better prospective studies. That review included studies showing a better QoL among
stoma patients. In Study IV, QoL in patients with a stoma was lower than in patients not having a stoma after
surgery for rectal cancer. The fairly low response rate in this study must be taken in consideration. However,
all patients operated for rectal cancer between 1996 and 2004 in the catchment area and alive 2008 were
invited to participate. Other studies have often exclude patients with recurrent or metastatic disease or
patients who are expected to have difficulties understanding questions or the language.
Compared to normal Swedish population, the entire group operated for rectal cancer had an inferior QoL in
several respects, this being more pronounced among patients with a stoma.
In the stoma group, a bulge or a hernia around the stoma had additional impact on HRQoL and pain
associated with the stoma was significantly more pronounced in this group. Previous studies have shown sex
life and body image to be affected when having a stoma16,62,84,85. Stoma patients rated body image was rated
significantly inferior, and an expected consequence might be interference with sex-life, but this was not
shown in the present study. Patients without a stoma had significantly more sexual problems, which has also
have been shown in earlier studies86. On the other hand, a bulge/hernia in the stoma group was associated
with considerable sexual problems.
Previous studies have reported that a stoma affects the patient´s financial situation16. In our study the
financial situation only tended to be affected by having a stoma. Reasons for this might be taking time off
work due to visits to medical care and stoma-therapists, and the fact that 20% of stoma-patients needed
acute medical care due to the stoma. Having a stoma had a negative effect on appetite. The reason for this is
not known but it might depend on having to change the stoma dressing, and a feeling of being unclean.
Constipation and diarrhoea affected patients without a stoma more than stoma patients, in agreement with
the report by Digennaro et al85.
The incidence of parastomal hernia incidence has not been established and reports range between a few
percent to more than seventy11. In this cohort, the prevalence was at least 31.5%, though the true proportion
was probably higher as one third of the stoma patients did not answer that question. However, the true
prevalence was certainly not below 12% as 12% had been reoperated due to parastomal hernia. In this
reoperated group, half of the patients stated that they still had a bulge or a hernia which might correspond to
a recurrence of their parastomal hernia. Repair of recurrence of a previously operated parastomal hernia is
even more challenging, but there are few studies in the literature covering this aspect11.
37
In conclusion a stoma had a negative impact on overall QoL and a situation with a bulge or a hernia around
the stoma further aggravated this negative influence. Pain and sexual problems were more pronounced when
having a bulge/hernia, and fear for leakage from the stoma significantly impaired the patient´s perception of
function of the stoma. However, the fairly low response rate must be taken into consideration when
interpreting the results. The prospective collection of HRQoL data would probably give invaluable
information and should be given priority.
Improving the ability to correctly diagnose a parastomal hernia is essential, and 3D US is a promising
alternative to CT. In order to evaluate the negative predictive value of this technique, a larger study cohort in
need of surgery with or without s parastomal problem is planned.
None of the current methods used to treat parastomal hernia has shown to be superior. Recurrence and
complication rates are. Mesh repair is probably the most promising method, but we have still to find the most
suitable material and placement of the mesh. The PHP showed no advantage over other meshes. Future mesh
studies are needed, and promising materials include biological implants as well as implantation of
autologous tissue as prosthetic material.
The most appealing is to avoid parastomal hernia developing after the index operation. Studies on
prophylactic mesh have shown low parastomal hernia rates, but these studies are small with differing mesh
materials45. There are reports claiming no difference in rate of parastomal hernia with or without
prophylactic mesh46.Furthermore, the potential negative side effects have not been sufficiently evaluated.
Larger randomised studies are called for. STOMAMESH, a randomised controlled multicentre study
currently running in Sweden, randomises patients to prophylactic reinforcement with sub-lay mesh or not
when creating a permanent stoma. The inclusion goal will be reached during 2015 and a first report from
one-year follow-up data can be published in 2016. Beside the primary endpoint, parastomal hernia,
secondary end-points include mesh-related complications and HRQoL. A future study will involve plan in-
depth interviews using of qualitative methodology, and will include patients from the randomised cohort. We
hope this will further add to our understanding of the patient´s perspective.
A farm-worker impaled on a broomstick in 1750 was probably saved by the spontaneous development of a
stoma. The early days of were overshadowed by the enormous risk of fatal outcome, and in retrospect
enormous progress has been made in reducing risk, improving survival and reducing morbidity. Today a
stoma can be avoided in many cases, but is unavoidable in others. A stoma has great impact on the patient´s
life and in this thesis QoL was clearly shown to be reduced. HRQoL is important and must be taken into
account in all form of healthcare if we are to give the patient the best QoL possible. Hippocrates oath for good
medical care was stipulated centuries ago and a modern version states: “Never do harm, if possible cure,
often palliate and always comfort”. This must surely direct our choice of method for treatment and the use of
PHP does not fulfill these criteria. To find an effective low-risk treatment for parastomal hernia is of
paramount importance and this should be a field of research that is given high priority.
38
Acknowledgements
A PhD thesis is nothing one can accomplish without the support and help of others. I would like to thank all
those who gave me this vital endorsement and support.
Jörgen Rutegård; my first supervisor who persuaded me to start on this journey. You have been a great
support, believing in my ability when I doubted. AND Karin Strigård; my present supervisor who has always
been there to help and support. Thank you for all the stimulating conversations and sharing of thoughts over
meals.You have both given me critical feed-back and shared your knowledge while I climbed the learning
curve of scientific research.
Our research group, with Professor Ulf Gunnarsson as its founder, has beenan important forum for
challenging debate that has sharpened our arguments and objectives in the field of colo-rectal research. My
thanks go to all of you who participated in the meetings of this extraordinary group. Ulf – thank you for
inviting me to join this group. You have been one of my co-supervisors and I have really been impressed by
your capacity to maintain the focus of such a large group or workers, and remain always eager to help
whenever I send an e-mail.
Michael Dahlberg; co-supervisor and colleague. Thank you for making it possible for me to accomplish my
research in a reality where every-day work can be a great obstacle. You have given me time necessary for me
to reach the goal.
My co-writers Ambatchew Gurmu, Thyra Löwenmark, Ursula Dahstrand, Lars Påhlman and Franciska
Wikner; thank you all for your participation and fruitful discussions.
Research nurse Lisa Eskilsson. It was your appearance on the scene that actually gave me the strength to
continue my research. Thank you for being a phenomenal organiser and for all your thoughtfulness. When I
rushed into things you always came with a new point of view after taking a lot of aspects into consideration.
Robert Lundqvist. Statistics was a quite new area for me, and your knowledge is a bit more thorough than
mine – well actually you outclass me. But over the past few years I have learned a lot from you and you have
been a tremendous help with SPSS and work with the data-base – thank you!
An important base on which to build research is its economic funding. I would like to send a bunch of roses
to Karin Jones, head of the Centre for Research and Education (FoU) in Norrbotten and her co-workers. The
Centre provided economic funding for all the weeks designated for research and for the equipment, travels
and meetings necessary. Special thanks to Therese Sundbom and Annsofie Nilsson for all forms of
administrative help.
Eva Borin, my dear friend and former colleague. Your support throughout the years has been priceless.
Christoffer Odensten - thank you for being my co-worker and for all small-talk at numerous coffee breaks.
Ulf Öhrvall – thank you for your efforts to place research on the agenda at our department. I would also like
to take the opportunity to thank all surgical colleagues, nurses and all other personnel at Sunderby hospital.
Having close friends is a gift that gives strength and support in life. Bengt and Marie, Anders and Lena, Åsa
and Arne, Caroline and Martin, just to mention a few – I am grateful to each and everyone. A special thanks
to Jeanette Johansson, my close friend and Associate Professor, the Department of Business Administration,
LTU, for all “fika” small-talk and all scientific and work-related discussions.
Anna and Sune, my dear parents, without your support and trust in my ability, I would probably not have
become what I am today. Åsa and Pär and your families are very important to me. Birgit and Kenneth I know
I always can come to you with my worries and happiness. Thank you all! Finally, Erik, Emil, Johan, Oskar
and Olof – you are the joy and most important part of my life. I know I probably work too much, and I know I
am often away from home – thank you for accepting this and letting me take the time to complete my thesis.
1
2
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