surgery for rectal cancer op3mizing outcomes · - picture from gordons principles and practice for...
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SurgeryforRectalCancerOp3mizingOutcomes
Jose G. Trevino, MD FACS Assistant Professor
Department of Surgery
Disclosures
None
Thank you Dr. Atif Iqbal
Is Rectal Cancer a Different Beast?
Yes
Is Rectal Cancer a Different Beast? • Anatomy
• Complications specific to rectal surgery
• How do we make a difference? • National Rectal Cancer
Accreditation Program
Netters Atlas of Human Anatomy 2011
Complica3onsofPelvicSurgery• Presacral bleeding
– Presacral venous system
• Autonomic nerve injury – Urinary & sexual dysfunction
• Superior hypogastric plexus and/or hypogastric nerve
• Inferior hypogastric plexus and efferent pathways
Orkin BA. Rectal carcinoma: treatment. In: Beck DE, Wexner SD, eds. Fundamentals of Anorectal Surgery. New York: McGraw-Hill; 1992:260–369
- Picture from Gordons Principles and Practice for surgery of the Colon Rectum and Anus. Third edition
Complica3onsofPelvicSurgery• Presacral bleeding • Autonomic nerve injury • Local recurrence
• Significant problem: – Circumferential Resection Margin (CRM) +ve pts à 12 times
higher local recurrent rates 1 à 3 times higher mortality
• How to decrease it?
– TME dissection: CRM positivity (25% à 7%)
1. Kusters et al. Patterns of local recurrence in rectal cancer; a study of the Dutch TME trial. EJSO Volume 36, (5)2010, 470–476
Complica3onsofPelvicSurgery• Bleeding • Autonomic nerve injury • Local recurrence • Ureteral injury
DifferencesinPelvicSurgery• Bleeding • Autonomic nerve injury • Local recurrence • Ureteral Injury • Higher costs
– OR time • LARs and APRs take longer than colectomies
– Complications • Specific to operating in the pelvis • Approx. $80/min • OR time adds up
Haug U, Engel S, Verheyen F, Linder R (2014) Estimating Colorectal Cancer Treatment Costs: A Pragmatic Approach Exemplified by Health Insurance Data from Germany. PLoS ONE 9(2): e88407.
DifferencesinPelvicSurgery• Bleeding • Autonomic nerve injury • Local recurrence • Ureteral injury • Higher costs • Longer OR times • Quality of care? (Inherent)
– Longer LOS – Readmissions (dehydration) – SSIs – UTIs
Cananythinghelp?• TME
Cananythinghelp?• TME • Laparoscopy
2 Prospective RCT’s since last year: – ACOSGO Z6051 Trial:
• Successful resection (82% of lap and 87% of open cases) • Negative circumferential resection margin in 90% overall (88% of
lap and 92% of open) • RESULT: Laparoscopic resection compared to open resection
FAILED to meet the criteria for non-inferiority for pathologic outcomes
– ALaCart Study: • Successful resection in 82% lap vs. 89% open cases • Negative CRM margin in 93% lap and 97% open cases • RESULT: Non-inferiority of laparoscopic surgery was NOT
established
• Fleshman et al. JAMA 2015 Oct • Stevenson AR et al. JAMA 2015 Oct
Cananythinghelp?• TME • Laparoscopy • Robotic surgery
Robotic vs. Lap: – Does DaVinci help in the pelvis? à Maybe (Only 1 RCT (n=66) & few meta-analysis):
– Lower EBL & No difference in OR time in the LAR subset ONLY
Bianchi et al. Laparoscopic and robotic total mesorectal excision in the treatment of rectal cancer. Brief review and personal remarks. Frontiers in Oncology 2014; 4 (98)
Study Conversion % p
Hospital days p
Complication % p
Rob Lap Rob Lap Rob Lap
Kim/ Kang 2 3 1 11.7 14.4 0.001 20 27 0.4
Kwak 0 3.4 0.4 - - - 32 27 NS
Baek 7.3 2.2 0.116 6.5 6.6 0.8 22 27 1
Bianchi 0 4 NA 6.5 6 0.4 16 24 0.5
Baik 0 10.5 0.01 5.7 7.6 0.001 11 19 0.02
Patriti 0 19 0.05 11.9 9.6 0.05 31 19 0.05
Cananythinghelp?• TME • Laparoscopy • Robotic surgery • Ureteral stents
Cananythinghelp?• TME • Laparoscopy • Robotic surgery • Ureteral stents • Newer techniques
• Transanal TME – Distal third of rectum
•
• Role in ‘difficult pelvis’ patients to provide sphincter saving option?
Cananythinghelp?• TME • Laparoscopy • Robotic surgery • Ureteral stents • Newer techniques • Case volumes
• Significantly more low volume surgeons performed open TME
• Significantly more high volume surgeons: • Identified autonomic nerves during dissection (p<0.001) • Visualized ureters (p<0.001) – Significantly less time to do the anastomosis – Had significantly less conversion rates for lap cases
Cheung YM. Surg Endosc. 2009 Dec;23(12):2796-801. Current technique of laparoscopic total mesorectal excision (TME): an international questionnaire among 368 surgeons.
Clinicalprac3cevolumes&outcomes
• Cochrane review for CRS cases & volumes: – 54 studies with 943,728 pts (51 meta-analysis)
• Addressed volume-outcome relationship in CRS
– High volume hospitals – High volume surgeons – Colorectal trained surgeons
– Significantly improved 5 yr survival – Significantly improved operative mortality – Significantly lower rates of ostomies and APRs
Shah PR, Joseph A, Haray PN (2005) Laparoscopic colorectal surgery: learning curve and training implications. Postgrad Med J. 81(958):537–540
Clinicalprac3cevolumes&outcomes
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LapAPROpenAPR
Cananythinghelp?• TME • Laparoscopy • Robotic surgery • Ureteral stents • Newer techniques • Case volumes • A specialized surgeon?
• Colorectal specialization: – Edmond, Canada Registry:
• 683 patients, 52 surgeons
• Improved local recurrence rates and disease-specific survival • Upheld in multivariate analysis, controlling for confounding variables
SpecializedSurgeon?
VariableColorectalTrained
Pvalue+ -
Lowandmidrectalcancer(%) 71% 62% <0.001
Lowanteriorresec3ons(%) 61% 26% <0.001
Abdominoperinealresec3ons(%) 27% 47% <0.001
Porter et al. Ann Surg 1998
• Colorectal specialization: – Patients operated on by General Surgeon were 3.42 times more likely
to develop a local recurrence than those operated on by Colorectal Surgeons
SpecializedSurgeon?
- Harmon et al. Ann Surg 1999 - Dorrance et al. Dis Colon Rectum 2000
• Colorectal specialization • Good TME dissection à Circumferential margin • Distal resection margin • Reconstructive techniques • High volume • Other considerations:
– Type of resection (Lap, Robotic, Transanal endoscopic microsurgery TEM)
– No resection (complete clinical response CR) – Timing of resection
SpecializedSurgeon?
Cananythinghelp?• TME • Laparoscopy • Robotic Surgery • Ureteral stents • Newer techniques • Case volumes • A specialized surgeon • Quality Improvement Projects
– Ileostomy related morbidity reduction
QualityImprovementProjects
• Dehydration after ileostomy creation is the most common indication for readmission.
• It affects: – Length of Stay – Readmission – Reimbursement à era of assessment of quality and outcome measures
• Historic rates range from 10% to 40%
TheIssue
• MeanLOS:17days• LOSIndex:2.4• Readmissionrate:65%
2011 2012
IleostomyPhoneCallProtocolIns3tuted
Quality-metricoutcomecomparisonofpreandpost-interven:ongroups:Pre-
Interven:onPost-
Interven:onpvalue
Allileostomypa:ents:
-30-dayreadmissionrate(%) 65% 16% 0.004Readmissionpopula:on:
RESULTS
4.3
3
2.5
3
3.5
4
4.5
Pre-Intervention Post_Intervention
LengthofStay(days)
CostAnalysisfortheinterven:on:
*AssumestheaveragewageofaNursePrac33onerinFloridabeing$87,653perannumwith2,000workinghours/yearand~15minutes/dayrequiredtocompletetheques3onnaire
Costanalysis Cost/annumOverallCostSavings
CostReduc:on:
$63,821
- 49%decreaseinre-admissions $48,821- >1daydecreaseinhospitalstayfor
readmissions $15,000
Costofadministra:on:
Costofadministeringques:onnairethroughNursePrac::onersinthefuture:
$2,030* $61,791
OpportunityCostGain:
Poten:algainbytheupstreamchoiceofanalterna:veinthefreedhospitalbeds $112,114
TotalCostSavings: $173,905
Timeline
• MeanLOS:17days• LOSIndex:2.4• Readmissionrate:65%
2011 2012
• MeanLOS:12.3days• LOSIndex:1.33• Readmissionrate:29%
IleostomyPhoneCallProtocolIns3tuted
Timeline
•MeanLOS:17days• LOSIndex:2.4•Readmissionrate:65%
2011 2012 Jan2015 Oct2016
•MeanLOS:12.3days• LOSIndex:1.33•Readmissionrate:29%
•MeanLOS:7.8days• LOSIndex:0.94•Readmissionrate:*
•MeanLOS:4.8days• LOSIndex:0.58•Readmissionrate:30%
Post-operativePhoneCallProtocolInstituted
EarlyDCProtocol(PICCline+IVF)Instituted
ERASProtocolInstituted
Dec2015
•MeanLOS:11.7days• LOSIndex:1.07•Readmissionrate:28%
Timeline
•MeanLOS:17days• LOSIndex:2.4•Readmissionrate:65%
2011 2012 Jan2015 Oct2016
•MeanLOS:12.3days• LOSIndex:1.33•Readmissionrate:29%
•MeanLOS:7.8days• LOSIndex:0.94•Readmissionrate:*
•MeanLOS:4.8days• LOSIndex:0.58•Readmissionrate:30%
Post-operativePhoneCallProtocolInstituted
EarlyDCProtocol(PICCline+IVF)Instituted
ERASProtocolInstituted
Dec2015
•MeanLOS:11.7days• LOSIndex:1.07•Readmissionrate:28%
Timeline
• MeanLOS:17days• LOSIndex:2.4• Readmissionrate:65%
2011 2016
• MeanLOS:5days• LOSIndex:0.58• Readmissionrate:30%
• LOSforReadmission:13.7days• Dehydra3on-relatedreadmissionrate:65%• %ofreadmissionsduetodehydra3on:80%• Meancost(Indexprocedure):$49,359• Meancost(Readmission):$88,858
• LOSforReadmission:3.8days• Dehydra3on-relatedreadmissionrate:12%• %ofreadmissionsduetodehydra3on:37%• Meancost(Indexprocedure):$22,030• Meancost(Readmission):$19,588
Cananythinghelp?• TME • Laparoscopy • Robotic Surgery • Ureteral stents • Newer techniques • Case volumes • A Good Surgeon • Quality Improvement Projects
– Ileostomy related morbidity reduction – Prediction of difficult cases
Predic3onofa‘difficult’pelviccase• 20 cases each of ‘Routine’ and ‘Difficult’ pelvic dissections:
– Significant findings
Routine n (%)
Difficult n (%) p value
Males 6(30%) 14(70%) 0.01BMI >30 1(11%) 8(89%) 0.008Any Preop Radiation 11(42%) 15(58%) 0.3
XRT within 3 months 9 (60%) 6 (40%) 0.5
XRT beyond 3 months 2 (18%) 9 (82%) 0.03
EBL (mL) 271 746 0.01
Hospital Stay (days) 7.4 11.3 0.02
OR time
< 5 hrs 8(80%) 2(20%)0.02
> 5 hrs 12(40%) 18(60%)
Measurements Routine (mean)
Difficult (mean) p value
PelvicInlet
AP(mm) 127 101 <0.00001
Lat(mm) 125 89 <0.00001
Pelvicoutlet
AP(mm) 108 81 <0.00001
Lat(mm) 107 80 <0.00001
MidPelvis
AP(mm) 129 100 <0.00001
Lat(mm) 116 91 <0.00001
PelvicVolume
Bonyvolume(cm3) 535 383 <0.00001
Soj3ssuevolume 348 165 <0.00001
PelvicLength
Promtococcyx(mm) 125 134 0.06
Promtopelvicfloor 123 140 <0.00001
PelvicDepth
Anterior(mm) 40 45 0.08
Posterior(mm) 125 134 0.06
Sacrococcygealcurve(mm) 128 189 <0.00001
Pubistolevators(mm) 49 58 0.002
Anorectalangle 132 116 0.001
Rectalmassdiameter(mm) 37 34 0.2
Results:Predic3onModel• Made a practical prediction model for a difficult pelvic case:
– We chose 3 easily acquired factors with the strongest association with a ‘Difficult case’. A model was reached where p<0.00001, R2 (co-efficient of determination) was 0.98
– Called it ‘Pelvic Surgery Difficulty Index’ (PSDI)
PSDI Score p value
Male sex 1
<0.0001 History of neoadjuvant XRT 1
Length from promontory to pelvic floor > 130 mm 1
Total score Maximum of 3
Valida3onofPredic3onModel• Validated in another cohort of 347 patients
• Higher scores were significantly associated with: – Increased blood loss (0=211 ml vs. 3=412 ml) – Longer operative time (0=217 min vs 3=289 min) – Longer hospital stay (0=6 days vs 3=10.8 days) – Higher postoperative morbidity:
• More autonomic nerve injury: – Sexual dysfunction – Short and long-term urinary dysfunction
• ? Higher Cost ($13,433 vs $30,442, p=0.06)
• Validated PSDI model: – High sensitivity (0.95) and specificity (0.90) – Goodness of fit tests (Pearson and Deviance) being insignificant, demonstrating
a well-fitting model (p<0.0001)
Cananythinghelp?• TME • Laparoscopy • Robotic surgery • Ureteral stents • Newer techniques • Case volumes • A Good Surgeon? • Quality Improvement Projects
– Ileostomy related morbidity reduction – Prediction of difficult cases – Re-admission prediction model
Re-admissionpredic3onmodel• All ileostomy pts from 2013-2016 (86 patients):
– 26% re-admitted – Mean cost of re-admission: $13,839
– Major cause of re-admission was ‘dehydration’ from: 1. High ileostomy output (45%) 2. Ileus (18%)
– Factors associated with re-admission: • Baseline steroid use • History of diabetes • History of depression • Complications of bowel obstruction and high ostomy output during the index admission • Lack of postoperative ostomy teaching • Lack of discharge planning by social workers • Discharge with a PICC line
Re-admissionpredic3onmodel• Predictive model to stratify patient’s risk of readmission after the index procedure was
developed:
• Sensitivity: 73% and specificity: 77% • Modification of the variables identified may help decrease the
readmission rate: – Preoperative weaning of steroid use – Better preoperative control of comorbidities – Dedicated postoperative ostomy teaching and – Ensuring social work participation in discharge planning
Cananythinghelp?• TME • Laparoscopy • Robotic Surgery • Ureteral stents • Newer techniques • Case volumes • A Good Surgeon • Quality Improvement Projects • Clinical Trials
ClinicalTrialsPROSPECT Trial: TNT Trial:
• Why? – All the reasons mentioned already
Na3onalCoCAccreditedRectalCancerCentersofExcellence
• Why? – All the reasons mentioned already – Multi-disciplinary effort:
• GI • Radiology à MRI • Med Onc • Rad Onc à Preoperative Radiation Therapy • Pathology • Surgery
Na3onalCoCAccreditedRectalCancerCentersofExcellence
• Why? • Radiology à MRI • MRI: Potential CRM involvement can be demonstrated on
preoperative MRI à Highly correlated with histological specimen
Na3onalCoCAccreditedRectalCancerCentersofExcellence
MRI-involvedCRM
MRI-clearCRM Pvalue
5yroverallsurvival 42% 62% <0.01
5yrdiseasefreesurvival 47% 67% <0.05
Localrecurrence 20% 7% <0.001
Taylor et al. Am J Clin Oncol 2014 CRM and Preoperative MRI
• Why? – All the reasons mentioned already – Multi-disciplinary effort – Poor state of Rectal Cancer care in the US:
Na3onalCoCAccreditedRectalCancerCentersofExcellence
• Poor state of Rectal Cancer care in the US: – Vast majority of surgery for rectal cancer performed by non-specialists
in low volume hospitals
– Rates of permanent colostomy variable and excessive1: • 40% surgeons ONLY performed APRs (nonrestorative resections) !!! • APR surgeons had higher mortality rates and longer lengths of stay • Restorative (LAR) surgeons were specialized by virtue of more pouch and
anorectal procedures • Another study with data from 21 states showed 50% cases were APR’s with
only 20% of counties had colostomy rates of <40%2
– Suboptimal adherence to evidence based guidelines
– Oncologic outcomes are very poor compared to Europe
Na3onalCoCAccreditedRectalCancerCentersofExcellence
1. Ricciardi et al. Dis Colon Rectum 2011 2. Ricciardi et al. Dis Colon Rectum 2010
• Why? – All the reasons mentioned already – Multi-disciplinary effort – Poor state of Rectal Cancer care in the US – Europe: Been there, done that !
Na3onalCoCAccreditedRectalCancerCentersofExcellence
• European story à Results: – Lower rates of LR and permanent colostomy – More patients receiving evidence based care with adherence to
guidelines – Increased recruitment to clinical trials – Improved monitoring of standards and outcomes – Rectal Cancer outcomes now exceed those of Colon Cancer in Europe
Na3onalCoCAccreditedRectalCancerCentersofExcellence
1. Khani & Smedh et al. Colorectal Dis 2010 2. Burlow et al. Colorectal Dis 2010 3. Ortiz H et al. Colorectal Dis 2013
• Where are we? – OSTRICH:
• Consortium for Optimizing Surgical Treatment of Rectal Cancer • Established in 2011 • Broad representation of pertinent societies:
– ACS, CoC, ASCRS, SSO, SSAT, SAGES, CAP, ACR • Highlighted the need for Rectal Cancer COE through multiple publications
and collaborations
Na3onalCoCAccreditedRectalCancerCentersofExcellence
• Where are we at UF? – UF à OSTRICH Member
– Established standardized evidence based protocols for Rectal Cancer: • Pathology reporting • MRI reporting • Treatment algorithms
– Leading a multi-disciplinary effort: • > 6 Departments • To establish RC-COE at UF
Na3onalCoCAccreditedRectalCancerCentersofExcellence
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