Is Laparoscopic Inguinal Hernia Repair an Operation of the Past?

COLLECTIVE REVIEWS Is Laparoscopic Inguinal Hernia Repair an Operation of the Past? Lorelei J Grunwaldt, MD, Steven D Schwaitzberg, MD, FACS, David W Rattner, MD, FACS, Daniel B Jones, MD, FACS There is an ongoing debate about whether to repair primary, unilateral inguinal hernias by the laparoscopic or the open method. Many agree that laparoscopic repair is better for bilateral or recurrent hernias, but its use for primary, unilateral hernias is controversial. Sixteen randomized, controlled trials and metaanalyses that compared these two techniques demonstrated that laparoscopic repair has a definite role in modern surgery (Table 1). The VA Cooperative Study is the most recently published large, prospective, randomized, controlled trial that compared laparascopic to open repair. The authors concluded that open inguinal hernia repair is superior to laparoscopic inguinal hernia repair. They based their conclusion on a higher overall recurrence rate in the laparoscopic group (10% versus 4.9%) and a higher complication rate in the laparoscopic group (39% versus 33%). 1 This article might make one believe that laparoscopic inguinal hernia repair is a procedure of the past. A thorough analysis of this admirable and ambitious project reveals many flaws; it simply cannot be accepted as the definitive work in this field. In this article we will discuss the drawbacks of the VA Study, and we will also delineate the shortcomings of some of the other published reviews in an attempt to illustrate why laparoscopic inguinal hernia repair is not a procedure of the past. Hernia revisited Hernia comes from the Greek word hernios, which means offshoot or bud. In his book entitled Hernia, Nyhus 2 stated, The history of hernia repair is the history of surgery. It might seem that advancements in hernia surgery have surpassed the work of early surgeons. Lau, 3 in his history of inguinal hernia repair, pointed out Received August 20, 2004; Revised October 21, 2004; Accepted October 22, 2004. From the Departments of Surgery, Beth Israel Deaconess Medical Center (Grunwaldt, Jones), Tufts-New England Medical Center (Schwaitzberg), and Massachusetts General Hospital (Rattner), Boston, MA. Correspondence address: Daniel B Jones, MD, FACS, Department of Surgery, Beth Israel Deaconess Medical Center, Shapiro TCC 355, Boston, MA 02215. that early laparoscopic surgery failed because the tenets of open surgery were not followed. When the basic principles of hernia surgery were revisited, laparoscopic methods began to succeed. To ensure low complication and recurrence rates, it is essential to have a complete understanding of the anatomy of the inguinal region. In his 1804 monograph, Cooper stated, No disease of the human body, belonging to the province of the surgeon, requires in its treatment a greater combination of accurate anatomic knowledge, with surgical skill, than hernia in all its varieties. 4 The VA Trial failed to monitor or standardize the techniques used for repair. The VA Study versus hernia repair in the 21 st century After appendectomy, hernia repair is the most frequently performed general surgery operation. In the United States, there are more than 700,000 repairs performed each year. 5 McKinsey and Co estimated that laparoscopic inguinal herniorraphy would become the procedure of choice a few years after it was introduced. They predicted that from 1993 to 1995, 50% of all repairs would be done laparoscopically. Today, the number of inguinal hernias repaired by the minimally invasive technique is well below 50%. Why? The recommendation of the National Institute of Clinical Excellence (NICE) states that open mesh repair should be the procedure of choice for primary inguinal hernia and that the laparoscopic approach should be limited to bilateral or recurrent hernia. 6 Laparoscopic inguinal hernia repair is a safe and reasonable procedure. The complication rate is very low, comparing favorably with open repair (Table 2). The VA Cooperative Study concluded that the rate of complications was higher in the laparoscopic group (39%) than in the open group (33%). It did not break down the complications according to whether a transabdominal preperitoneal (TAPP) or total extraperitoneal (TEP) repair was done. One large metaanalysis found that TAPP repair has a higher rate of serious complications than TEP, with vascular and visceral injuries more frequent in the 2005 by the American College of Surgeons ISSN 1072-7515/05/$30.00 Published by Elsevier Inc. 616 doi:10.1016/j.jamcollsurg.2004.10.033

Vol. 200, No. 4, April 2005 Grunwaldt et al Laparoscopic Inguinal Hernia Repair 617 Table 1. Studies Comparing Open and Laparoscopic Hernia Repair Randomized controlled trials/metaanalyses, First author Type of repair Neumayer (VA Cooperative Study) 1 Grant 7 McCormack 8 Memon 9 MRC Lap. Groin Hernia Trial Group 10 Lap versus open (433/460 mesh) Johansson 11 Lap versus open (mesh & nonmesh grouped) Bringman 12 Liem 13 Juul 14 Picchio 15 Andersson 16 Champault 17 Stoker 18 Lawrence 19 Chung 20 Lap versus open (mesh and nonmesh grouped) Wright 21 Lap, laparoscopic. laparoscopic group (4.7/1,000 versus 1.1/1,000). 7 The VA study analyzed the recurrence rate in surgeons who had done more than 250 laparoscopic repairs, but it did not examine the complication rate in this group. It is also significant that in the VA Study, there were two deaths within 30 days of surgery in the laparoscopic group. The authors believed that these deaths were related to the operation. Were the deaths in the group who had TEP or TAPP? There were no early deaths in the open group. The recurrence rate after laparoscopic inguinal hernia repair can be seen in Table 3. As the table illustrates, there is not a significant difference in recurrence rates between laparoscopic and open repair. The VA Trial found a higher recurrence rate after laparoscopic repair (10.1% versus 4.9%). This rate is significantly higher than that quoted in other articles (Table 3). Interestingly, there was a lower recurrence rate in the laparoscopic repair for recurrent hernias. Post hoc analysis demonstrated that surgeons who had done more than 250 laparoscopic repairs had a 5% recurrence rate; this rate is half that for less experienced surgeons. This may be testimony to the steep learning curve for laparoscopic repair. But 250 repairs are many more cases than most Table 2. Complications McCormack 8 distinguishes visceral injury from vascular Memon 9 Grant 7 8/2,315 visceral 7/2,498 vascular 38% risk reduction 15 serious complications 1/2,599 visceral 5/2,758 vascular 4 serious complications MRC Lap. Groin Hernia Trial Group 10 5.6% 1.4% Bringman 12 No significant difference No significant difference Andersson 16 No significant difference No significant difference Lawrence 19 12% 2% (p 0.02) Neumayer 1 39% Surgeon 250 patients, 4.1% complication rate; Surgeon 250 patients, 12.3% complication rate 33.4% Surgeon 250 patients, 5.1% complication rate; Surgeon 250 patients, 2.5% complication rate experienced laparoscopic hernia surgeons consider necessary to gain expertise. The trial reported a very high rate of conversion to open surgery. This is disturbing as well. The recent clinical trial that compared open with laparoscopic colectomy required surgeons to submit a video that demonstrated competence in performing the procedure before entering cases in the study. This type of quality control is needed in a technique-dependent surgery trial. Those who advocate laparoscopic repair believe it is superior for several reasons. Postoperative pain is decreased and there is a shorter recovery time. The repair enables one to inspect both groins for a potential hernia Table 3. Recurrence McCormack 8 No significant difference No significant difference Grant 7 No significant difference (2.3%) No significant difference (2.9%) MRC 10 1.9% 0 Liem 13 3% 6% Champault 17 6% 2% Chung 20 No early significant difference in all groups Neumayer 1 10.1% (recurrence after primary repair); 10% (recurrence after repair of recurrent hernia) 4.9% 14.1% (no significant difference)

618 Grunwaldt et al Laparoscopic Inguinal Hernia Repair J Am Coll Surg Table 4. Return to Usual Activity McCormack 8 56% earlier (p 0.0001) Memon 9 4.7 d shorter (p 0.001) Grant 7 More quickly in 24 trials (p 0.001) MRC 10 10d 14d(p 0.004) Johansson 11 18.4 d 24.2 d mesh versus 26.4 d nonmesh Bringman 12 14 d 24.5 d plug versus 28.5 d Lichtenstein (p 0.0001) Liem 13 6 d 10 d Picchio 15 6.5 wk 6.1 wk (p 0.03) Andersson 16 13 d 19 d Stoker 18 3d 7d(p 0.001) Lawrence 19 No significant difference No significant difference Chung 20 Laparoscopic shorter in all groups Neumayer 1 4d 5d that was not clinically diagnosed and to avoid the scarred operative site when repairing a recurrent hernia. The surgeon is able to use the mesh to cover entirely the myopectineal orifice. The large metaanalyses, and the VA Trial, confirmed that laparoscopic repair leads to less postoperative pain, a shorter convalescence, and faster return to work. 7-9,20 Tables 4, 5, and 6 illustrate these points well. The procedure takes longer to perform and is more costly (Tables 7 and 8). Many of the studies compare laparoscopic repair with open tension repairs such as the Bassini or Shouldice repairs (Table 1). It has been shown that pain is less and recurrences are lower with open tension-free repairs. 22 The VA Cooperative Study was designed more appropriately in that all open repairs were tension-free Lichtenstein repairs. Although it seems clear that several of the conclusions of the VA Trial are questionable, the study has been published during a time when many are looking for a reason to doubt the validity of laparoscopic inguinal hernia repair. This may be due, in part, to the way that the majority of metaanalyses and randomized controlled trials are conducted. There are several drawbacks to many of the conclusions gleaned from the larger body of published literature. The analysis of postoperative pain and return to work exemplify this phenomenon. The time to return to work was analyzed in several articles. The data are rather subjective. It is clear that the type of work to which a patient is returning will influence how long he needs to be away from work. For Table 5. Return to Work Memon 9 6.9 d shorter (p 0.001) Johansson 11 14.7 d (p 0.05 and 0.04) 17.7 d mesh versus 17.9 d nonmesh Bringman 12 5d 7d(p 0.02) Liem 13 14d 21d(p 0.005) Juul 14 13d 18d(p 0.005) Picchio 15 6.5 wk 6.1 wk (p 0.03) Andersson 16 8d 11d(p 0.003) Champault 17 17d 35d(p 0.01) Stoker 18 14d 28d(p 0.002) Lawrence 19 No significant difference No significant difference example, a patient with a job that entails heavy lifting might need a much longer time away from work than someone who sits at a desk. Some patients might be receiving pay while they are on sick leave, so they have less of an incentive to go back to work. 23 Many studies do not address these variables. There seem to be several issues that were not addressed consistently regarding assessment of postopera- Table 6. Pain McCormack 8 290/2,102 459/2,399 (p 0.0001) Grant 7 12/16 studies favor lap (p 0.08) MRC 10 28.7% 36.7% (p 0.018) Bringman 12 VAS score lower for lap (p 0.015) Juul 14 2.1 d of pain medication 2.7 d of pain medication (p 0.02) Picchio 15 VAS 2.3 VAS 1.8 (p 0.03) Andersson 16 5 g acetominophen 11 g acetominophen (p 0.0001) Champault 17 VAS 3 higher day 1 VAS 5 higher day 2 VAS 6 higher day 3 (p 0.0001) Stoker 18 8 tabs 6 tabs (p 0.001) Lawrence 19 13% used 20 tablets 32% used 20 tablets (p 0.01) Chung 20 Group 1-nosignificant difference Group 2 - less in lap Group 3 - less in lap Wright 21 2 doses pain medication 2.5 doses pain medication (p 0.008) Neumayer 1 10.2 point difference in VAS favoring lap repair lap, laparoscopic; VAS, Visual Analogue Scale.

Vol. 200, No. 4, April 2005 Grunwaldt et al Laparoscopic Inguinal Hernia Repair 619 Table 7. Length of Operation McCormack 8 14.8 min longer (p 0.0001) Memon 9 15.2 min longer (p 0.001) Grant 7 No significant difference No significant difference MRC Lap Groin Hernia Trial Group 10 58.4 min 43.3 min Bringman 12 50 min 36 min for plug and patch 45 min for Lichtenstein Picchio 15 49.6 min 33.9 min (p 0.001) Lawrence 19 72 min 32 min (p 0.0001) Chung 20 Laparoscopic longer in all groups Wright 21 58 min 45 min (p 0.0001) tive pain. One author commented on neuralgia inguinodynia and quoted a 20% rate of nerve entrapment. 24 The studies rarely mentioned whether the surgeon identified the ilioinguinal and iliohypogastric nerves during open dissection. Laparoscopic repair also puts several nerves at risk of entrapment and it is rarely mentioned whether the nerves were visualized or avoided during dissection. The topic of mesh fixation is also important in considering postoperative pain. Stoppa advocated placing the mesh without fixation in the preperitoneal space to avoid nerve injury. It is argued that if one uses a large enough piece of mesh, with good overlap, fixation is unnecessary. 25 The majority of articles did not mention whether the mesh was tacked or sutured in place in the laparoscopic arm of the study. Despite all of the caveats mentioned previously, it seems clear that there is a shorter recovery period and less postoperative pain after laparoscopic repair. The VA Cooperative Study concluded that open repair is better for primary inguinal hernias. This failed to take into account the patient s pain and postoperative recovery period. There is an undertone of reluctance in embracing laparoscopic inguinal hernia repair. As Kurzer and coworkers 5 stated, It is a testimony to the simplicity, safety, and effectiveness of open tension-free hernioplasty that the results from surgeons with no special Table 8. Cost MRC 10 314 more pounds Johansson 11 7,063 SEK 417 SEK (mesh) 0 SEK (no mesh) Andersson 16 $1,091 higher (p 0.001) Lawrence 19 850 pounds 268 pounds interest or expertise in hernia repair are identical to those with a special interest in the subject. The VA Study confirmed the need for a high degree of technical expertise to avoid high recurrence and conversion rates. A carefully conceived and executed study is needed to better define the role of laparoscopic inguinal hernia repair. Laparoscopic repair may not be a procedure for the average general surgeon unless one is committed to mastering technical expertise. The repair is a technically challenging procedure with a steep learning curve. There must be rigorous entry criteria for both patients and surgeons in a setting of consistent repair technique(s). The future will likely reveal that laparoscopic inguinal hernia repair, performed by the experienced surgeon, has a role in primary and recurrent inguinal hernia repair. REFERENCES 1. Neumayer L, Giobbe-Hurder A, Johansson O, et al. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med 2004;350:1819 1827. 2. Nyhus LM, Condon RE, eds. Hernia. 4 th ed. Philadelphia: Lippincott; 1995. 3. Lau WY. History of treatment of groin hernia. World J Surg 2002;26:748 759. 4. Rutkow IM. A selective history of groin hernia in the early 19 th century. Surg Clin North Am 1998;78:921 940. 5. Kurzer M, Kark A, Wantz G, eds. Surgical management of abdominal wall hernias. United Kingdom: Martin Dunitz Ltd; 1999. 6. Bloor K, Freemantle N, Khadjesari Z, Maynard A. Impact of NICE guidance on laparoscopic surgery for inguinal hernias: Analysis of interrupted time series. Brit Med J 2003;326:578 580. 7. Grant A. Laparoscopic compared with open methods of groin hernia repair: Systematic review of randomized controlled trials. Brit J Surg 2000;87:860 867. 8. McCormack K, Scott NW. Laparoscopic techniques versus open

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