The document discusses the debate around whether mesh should be tacked or not during laparoscopic hernia repair surgery. It summarizes several studies that found: 1) There was no difference in hernia recurrence rates whether the mesh was tacked or not. 2) Patients who did not have their mesh tacked experienced less post-operative pain and required fewer pain medications. 3) Tacking the mesh increased the cost and time of the surgery without providing clinical benefits. Therefore, the document concludes that laparoscopic hernia repair can be performed safely without the routine use of mesh fixation devices.

1. George S Ferzli, MD, FACS Giancarlo Cires, MD Courage and comfort, all shall yet go well” King John, Act ii, Scene 4 To Tack or Not to Tack

2. Disclosure George Ferzli, MD, FACS has been a consultant for: Baxter International, Inc. Covidien, Inc. To Tack or Not to Tack

3. 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” Why is there a question?

4. Preliminary TEP post-op studies showed that recurrence was due to technical error with a small percentage attributed to mesh migration. “ 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 prompted Surgeons 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. Why tack?

5. 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 Hernia Recurrence

6. "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. Is stapling mesh necessary to contain an enlarged or bilateral hernia?

7. 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 Mesh Migration

8. 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 Why not tack?

9. 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 Why not tack?

10. 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 Why not tack? … there may be no difference in recurrence rates

11. 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 Why not tack?

12. 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 Why not tack?

13. 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 Why not tack?

14. 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 Why not tack?

15. 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 Post Herniorrhaphic Groin Pain

16. 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 Why not tack?

17. 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 Why not tack?

18. 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 Why not tack?

19. Taylor C et al. Surg Endosc . 2007 Sept 21 … there may be more groin pain and no difference in recurrence Why not tack?

20. 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 Why not tack?

21. 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 2 nd review planned in 2008 to evaluate after 2 years Taylor 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 Why not tack?

22. 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? Why not tack? Khajanchee et al. Surg Endosc (2001) 15: 1102–1107

23. 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 An Alternative-Bioglue

24. 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 An Alternative-Bioglue

25. Lau H. Ann Surg . 2005; 242: 670-675 An Alternative-Bioglue

26. 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 group Lau H. Ann Surg . 2005; 242: 670-675 "It is the mind that makes the body rich” Taming of the Shrew, Act iv, Scene 3 Why not tack?-bioglue

27. • Cost of Staplers: $120 Cost of bioadhesive: $230 per 4ml Cost of repairing injury to bladder or bowel . . . Why not tack? It is costly. Peach, G. Small bowel obstruction and perforation due to a displaced spiral tacker: a rare complication of laparoscopic inguinal 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

28. 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 Conclusions

29. 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 Conclusions

30. 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. Finally

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