to tack or not to tack

George S Ferzli, MD, FACSGeorge S Ferzli, MD, FACS

Giancarlo Cires, MDGiancarlo Cires, MD

Courage and comfort, all shall yet go well” King John, Act ii, Scene 4

Disclosure

George Ferzli, MD, FACS has been a consultant for:

Baxter International, Inc.

Covidien, Inc.

Increase in hernia recurrence?

Increase in post-operative pain and cost.

Our doubts are traitors, and make us lose the good we oft might win, by fearing to attempt” Measure for Measure, Act i, Scene 5”

Preliminary TEP post-op studies showed that recurrence was dueto technical error with a small percentage attributed to meshmigration.

“Inadequate fixation of the mesh, particularly at the lower medial corner, was found to be a common cause for the recurrence of

inguinal hernia.”

Fear of hernia recurrence due to mesh migration promptedSurgeons to secure all mesh during laparoscopic repair operations

"Wisely and slow; they stumble who run fast” Romeo & Juliet, Act ii, Scene 3

Deans GT, Wilson MS, Royston CM, Brough WA. Recurrent inguinal hernia after laparoscopic repair: possible causes and prevention. Br J Surg. 1995; 82:539-541.

• Retrospective review of 10,053 repairs

• 35 repairs failed (0.4%)

Felix et al. Surg Endosc (1998) 12: 226–231

"My endeavours have ever come too short of my desires” Henry VIII, Act iii, Scene 2

Inadequate lateral fixation of the mesh was identified in 11 cases

"Have patience, and endure "Much Ado About Nothing, Act iv, Scene 1

“Above all, these studies frequently did not specify the dimensions of the hernial defect. The significance of the size of a hernial opening on the recurrence rate remains unknown.”

Khajanchee YS, Urbach DR, Swanstrom LL,Hansen PD. Outcomes of laparoscopic herniorrhaphy without fixation of mesh to the abdominal wall. Surg Endosc. 2001; 15: 1102-1107.

“In conclusion, mesh fixation in the TEP technique offers no clinical advantages and increases the cost of the process. Our results recommend limiting the use of mesh fixation in the laparoscopic

approach to cases of direct bilateral hernias.”

Randomized Clinical Trial of Fixation vs Nonfixation of Mesh in Total Extraperitoneal Inguinal Hernioplasty Alfredo Moreno-Egea MD, Jose Antonio Torralba Martinez, MD, German Morales Cuenca MD, Jose Luis Aquavo Albasini, MD Arch Surg. 2004;139:1376-1379.

Could early postoperative ambulation lead to displacement or folding of mesh?

Prospective study performed to duplicate stress of immediately sitting after surgery:

32 consecutive patients After placement of 15x15cm polypropylene mesh, the

preperitoneal space was desufflated, and the OR table was flexed and extended

The peritoneal space was then reinflated and the mesh affixed The mesh did not migrate either before or after fixation in any of

the 32 patients At 6-9 month followup, no recurrences were reported Average operative time was 29.6 minutes

Ferzli et al. Surg Endosc (2004) 18: 523–525

"What wound did ever heal but by degrees ?” Othello, Act ii, Scene 3

• Maybe there is no difference in recurrence rates

• Maybe tacking would generate more pain

• How many staples… and where to place them?

• The addition of stapling device increases costs

"Tis better to be brief than tedious” Richard III, Act i, Scene 4

• 100 repairs randomized to stapled vs not stapled

• All performed by the same surgeon

• All patients were evaluated by the surgeon at 1, 3 and 6 weeks; 6 months; and 1 year postoperatively;

Ferzli et al. J Am Coll Surg. Vol. 188, No. 5, May 1999

"Ignorance is the curse of God, knowledge the wing wherewith we fly to heaven” Henry VI, Act iv, Scene 7

…there may be no difference in recurrence rates

• No recurrences were found in either group

• There were no complications or deaths

• The cost using staples was estimated at $415 compared with $295 not using them

• Instruments and materials for the open procedure cost $255

Ferzli et al. J Am Coll Surg Vol. 188, No. 5, May 1999

Have more than though showest; speak less than thou knowest; lend less than thou owest” King Lear, Act i, Scene 4

…there may be no difference in recurrence rates

• Randomized multicenter trial of TEP vs conventional anterior hernia repair

• TEP repair performed without fixation of mesh

• Patients were followed and examined for recurrence and inguinal pain at 2, 3 and 5 years after surgery

• Open repair consisted of reduction of hernia, ligation of sac and/or reconstruction of the inguinal floor

Liem MS et al. Ann Surg. Vol 237: 1 Jan 2003

"They that thrive well take counsel of their friends” Venus & Adonis

…there may be no difference in recurrence rates

• Median follow up was 44 months

• 21 recurrences in laparoscopic group

• 43 recurrences in open group

• One surgeon was responsible for 10 of the 21 recurrences in the laparoscopic group

Liem MS et al. Ann Surg. Vol 237: 1 Jan 2003

…there may be no difference in recurrence

• 93 cases of chronic inguinal pain

• 69 open vs 24 laparoscopic

• Variables predictive of chronic pain were pre-op pain, open repair and lesion of the nerve during surgery

Liem MS et al. Ann Surg. Vol 237: 1 Jan 2003

…there may be no difference in recurrence

• The main nerves involved in the etiology of pain following laparoscopic hernia repair are the lateral femoral cutaneous, femoral and genitofemoral nerves.

• During a laparoscopic repair, one must avoid the “Triangle of Pain”

Ferzli et al. J Am Coll Surg, Vol. 205, No. 2, Aug 2007

"When sorrow comes, they come not single spies, but in battalions” Hamlet, Act iv, Scene 5

…there may be more groin pain

Ferzli et al. J Am Coll Surg, Vol. 205, No. 2, Aug 2007

"There was never yet philosopher that could endure the toothache patiently” Much Ado About Nothing, Act v, Scene 1

• Multiple cases of severe pain have been reported

• Appears to be secondary to nerve entrapment by the staples

• Re-exploration and removal of staples is required to relieve pain

Wong J et al. Surg Laparosc Endosc Percutan Tech 2001, 11: 2

Condemn the fault, and not the actor of it” Measure for Measure, Act ii, Scene 2

G Ferzli et al.

…there may be more groin pain

• Randomized prospective comparison of fixation vs no fixation of mesh

• Patients blinded

• 20 patients in each arm

• Followed up at 1, 4 and 12 months post-op

• Zero recurrences in each group

• Patients without fixation were less likely to be admitted and used less pain medication

Koch CA et al. JSLS (2006) 10: 457-460

“How poor are they that have not patience” Othello, Act ii, Scene 3

…there may be more groin pain

• 500 hernia repairs randomized to stapled vs not stapled

• Both patients and follow-up clinician were blinded regarding the use of mesh fixation

• Repairs performed by 4 surgeons

• Randomization was performed by hernia rather than by patient

• Patients were recalled for in-person clinical review after a minimum of six months

Taylor C et al. Surg Endosc. 2007 Sept 21

"Words without thoughts never to heaven go” Hamlet, Act iii, Scene 3

…there may be more groin pain and no difference in recurrence

Taylor C et al. Surg Endosc. 2007 Sept 21

…there may be more groin pain and no difference in recurrence

• 1 recurrence in fixation group (a lateral recurrence associated with an infolded mesh)

• Cost was 375 AUD less in nonfixation group

• Persistent pain was reported more often in pts with fixated mesh

• An association was found between the number of tacks and incidence of pain

Taylor C et al. Surg Endosc. 2007 Sept 21

…there may be more groin pain and no difference in recurrence

• 120 patients had bilateral TEP repairs (84 patients

had fixation on one side and not the other)

• Patients of this subgroup were 5 times more likely to

describe the nonfixation side as being more

comfortable

• 47 % versus 9%, p = 0.006

• 2nd review planned in 2008 to evaluate after 2 yearsTaylor C et al. Surg Endosc. 2007 Sept 21

"Love all, trust a few, do wrong to none” All's Well that Ends Well, Act i, Scene 1

…there may be more groin pain and no difference in recurrence

Ferzli et al. J Am Coll. Surg. Vol. 188, No. 5, May 1999

"Withold thine indignation, mighty heaven, and tempt us not to bear above our power” King John, Act v, Scene 6

…where to staple – and how many?

Khajanchee et al. Surg Endosc (2001) 15: 1102–1107

Application of bioglue sealant for mesh fixation was first described by Katkhouda et al in a swine model in 2001 (a biodegradable

fibrin adhesive reproducing the last step of the coagulation cascade).

“Better three hours too soon than a minute too late” Merry Wives of Windsor, Act ii, Scene 2

• 186 TEP hernia repairs randomized to either stapling or fibrin sealant

• Primary endpoints were severity of postoperative pain, analgesic requirement, and incidence of seroma

• Secondary outcome measures were operative time, LOS, recurrence rate, and incidence of chronic pain

Lau H. Ann Surg. 2005; 242: 670-675

“Its not enough to speak, but to speak true” Midsummer Night’s Dream, Act v, Scene 1

Lau H. Ann Surg. 2005; 242: 670-675

• The total pain meds taken by the FS group was

significantly less than the staple group

• No recurrences in either group

• Higher rate of seromas in FS group

• Chronic pain was 20% in staple group vs 13.2% in FS

groupLau H. Ann Surg. 2005; 242: 670-675

"It is the mind that makes the body rich” Taming of the Shrew, Act iv, Scene 3

• Cost of Staplers: $120

• Cost of bioadhesive: $230 per 4ml

• Cost of repairing injury to bladder or bowel . . . Peach, G. Small bowel obstruction and perforation due to a displaced spiral tacker: a rare complication of laparoscopicinguinal hernia repair. Hernia. 2007 Nov 20

Novik, B. Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair. Surg Endosc (2006) 20: 462–467

Ferzli et al. J Am Coll Surg Vol. 188, No. 5, May 1999

• Laparoscopic hernia repair can be performed safely without the use of fixation devices

• The routine use of staples for fixation of mesh is associated with higher rate of postoperative pain

Defend your reputation, or bid farewell to your good life for ever” Merry Wives of Windsor Act iii, Scene 2

• There is no consensus on the number of staples needed for adequate fixation or to their placement

• Fibrin glue is associated with less pain but is not without its own complications

If patient presents postoperatively

with chronic pain…

"Take honour from me, and my life is done” Richard II, Act i, Scene 1

– at least you

know

it’s not your

staples.

"The elements be kind to thee, and make thy spirits all of comfort: fare thee well !” Antony & Cleopatra, Act iii, Scene 2