Surg Clin N Am 83 (2003) 1141–1161 Laparoscopic repair for groin hernias Chad J. Davis, MD*, Maurice E. Arregui, MD Department of Surgery, St. Vincent Hospital and Health Center, 8402 Harcourt Road, Suite 815, Indianapolis, IN 46260, USA Laparoscopic inguinal herniorrhaphy was first described by Ger, Schultz, Corbitt, and Filipi in the early 1990s [1–4] and burst upon the surgical scene just after laparoscopic cholecystectomy. It rapidly became popular, and many different techniques for repair were developed. Over the last decade much good work has been done to find which type of laparoscopic repair is best, to determine whether the laparoscopic or open approach is better, and to develop and refine open tension-free repairs. Twenty to 30 years ago, Doctors Robert Condon, Lloyd Nyhus, Chester McVay, and the Shouldice Clinic surgeons stood almost alone in North America as champions of the proper study of inguinal hernia anatomy and repair. In the surgical community at large and in many residency programs in particular, herniorrhaphy was regarded as a second-class operation, relegated to the first 2 years of training. The approach in many training programs was to repair a hernia by apposing tough ‘‘stuff to stuff.’’ Few academic surgeons were interested in studying herniorrhaphy. That changed with the introduction of laparoscopic hernia repair and the tension-free, open repairs a little over a decade ago. Very quickly, hernia repair became a topic of intense study. The last 12 years have witnessed the publication of a large number of articles (descriptions of anatomy and technique, retrospective reviews, randomized controlled trials, systematic reviews, and meta-analyses), numerous meetings devoted to hernia, and the formation of cooperative hernia study groups and hernia societies in America and Europe and around the world. There has been no lack of energetic and thoughtful study of the subject, and much of this interest was sparked by the laparoscopic revolution and the constructive criticism (and sometimes acrimonious debate) between the laparoscopic and open camps. Open, tension-free mesh hernioplasty has also evolved and has been incorporated into surgical practice around the world in the last 12 years. * Corresponding author. E-mail address: [email protected] (C. J. Davis). 0039-6109/03/$ - see front matter Ó 2003 Elsevier Inc. All rights reserved. doi:10.1016/S0039-6109(03)00122-1 1142 C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 Because of its effectiveness, it has almost replaced sutured repair, so the current question is ‘‘Which is better, laparoscopic mesh repair or open mesh repair?’’ Despite the intense study and work devoted to laparoscopic herniorrhaphy, the penetration of this procedure into the practices of general surgeons in the United States, Europe, and around the world remains much less than originally projected by laparoscopic enthusiasts. It is performed mostly by surgeons specializing in this technique, and in many cases is limited to specific indications (bilateral or recurrent hernias). The authors will attempt to analyze why this is the case. Our purpose here is to summarize the work done so far and to attempt to answer these questions: Which hernia repairs are best? What are the benefits and drawbacks of the laparoscopic repair? Where do we stand now? Techniques and perioperative care Indications and contraindications for laparoscopic inguinal hernia repair The indications for laparoscopic repair are the same as with open repair. Contraindications (relative and absolute) include previous lower abdominal surgery, pelvic radiation, previous extraperitoneal surgery (radical retropubic prostatectomy), and patients with impaired cardiac or pulmonary status who are not good candidates for general anesthesia. Anatomy Several authors have studied and written about inguinal anatomy from a laparoscopic perspective [5–8]. Although this anatomy was studied previously in the development of the preperitoneal open hernia repair, when laparoscopic herniorrhaphy was developed. These authors revisited the subject and broke new ground in the understanding of preperitoneal anatomy. We will not detail that anatomy here but refer the reader to the reports listed above for further study. Techniques of laparoscopic hernia repair The two most common laparoscopic hernia repairs now are the transabdominal preperitoneal repair (TAPP) and the total extraperitoneal repair (TEP). Other laparoscopic techniques, such as closure of the internal ring, ring plasty, placement of a mesh plug and patch, and the intraperitoneal onlay of mesh (IPOM) have largely been abandoned, at least in America and Europe. Both the TAPP and TEP have the same basic principle of placing a piece of mesh in the preperitoneal space as described by Stoppa [9]. The difference is that the former requires an incision in the peritoneum to access the preperitoneal space, whereas in the latter, dissection is initiated and performed in the preperitoneal space. In either case, it is imperative to dissect C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 1143 the myopectineal orifice and surrounding structures completely. This means full exposure of the pubic bone medially and the space of Retzius, ‘‘removal of excess preperitoneal fat and cord lipomas, complete assessment of all potential hernia sites, full reduction of the direct sac, complete dissection of the proximal indirect sac from the cord and identification of the vas deferens and gonadal vessels’’ [10]. What follows is a general description of the two laparoscopic operations. Transabdominal preperitoneal repair (TAPP) This approach requires entry into the peritoneal cavity. The umbilical trocar is placed and insertion of the laparoscopic allows inspection of the inguinal area for the defect. Bilateral 5-mm trocars are placed one finger’s breadth below the level of the umbilicus just lateral to the rectus muscle. If a stapler is used, one of the lateral trocars needs to be 10 mm; however, 5mm spiral tackers are also available. A transverse peritoneal incision is made from the medial umbilical ligament extending laterally to the internal ring, just above the ring. The peritoneum and preperitoneal contents are bluntly dissected from the anterior abdominal wall, exposing the myopectineal orifice (the transversalis fascia). If mesh anchoring is not to be performed, dissection should be carried across the midline for a short distance. It is also important to dissect deep to the obturator vessels in the space of Retzius as well as widely, laterally, and posteriorly, to provide room for a large piece of mesh. If anchoring of mesh with staples or tacks is to be performed, a less extensive dissection may be done. Dissection is not complete until search is made for preperitoneal fat herniated through the internal ring (the so-called lipoma of the cord). The authors use polypropylene mesh. If the mesh is not anchored, it should measure 10 to 12.5 15 cm, should cross the midline and extend into the space of Retzius, and should cover the cord structures, extending laterally to the internal ring. It should overlap the hernia defect by a minimum of 4 cm. If the mesh is anchored, a smaller (10 14 cm) piece can be used. It is placed over the myopectineal orifice and anchored to Cooper’s ligament as well as superomedially and superolaterally. Because of the potential for nerve injury, staples or tacks should not be placed in the inferolateral region, below the iliopubic tract. (Some surgeons make a slit in the mesh to wrap around the cord. This can cause cord entrapment if too tight or allow herniation through the slit if left gaping.) Once the mesh is placed, the peritoneal defect is closed with staples or absorbable suture. Total extraperitoneal repair (TEP) This technique differs from the TAPP repair in that the peritoneum remains intact during the dissection and repair. Dissection of the preperitoneal space can be performed under direct vision (our approach) or by using a balloon dissector. In one ‘‘direct-vision’’ approach a cutdown 1144 C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 is made below the umbilicus into the preperitoneal space. The trocar is inserted and the laparoscope is introduced through the trocar, dissecting bluntly with the scope and insufflating with carbon dioxide to open up the space. In contrast, our ‘‘direct-vision’’ approach is to enter the peritoneal cavity first with a Veress needle for insufflation, then insert a 5-mm trocar into the peritoneal space. The inguinal regions are inspected. Then, under direct vision through a 30 angled 5-mm laparoscope, a 5-mm trocar is placed into the lateral aspect of the preperitoneal posterior rectus space— the space between the rectus muscle and the posterior rectus sheath (superior to the arcuate line) or between the rectus muscle and the peritoneum (inferior to the arcuate line). Blunt dissection is performed to create the preperitoneal ‘‘space,’’ and the space is then insufflated with carbon dioxide. A second 5-mm or 10-mm trocar is placed about 2 cm inferior to the umbilicus into the preperitoneal space through which the laparoscope is inserted. A third 5-mm trocar is placed on the contralateral side if bilateral hernias are being repaired, or just to the other side of midline if a unilateral hernia is being repaired. Once the preperitoneal space is entered, wide dissection is performed as with a TAPP operation. The entire myopectineal orifice is exposed, the hernia sac is reduced, and a search is made for herniation of preperitoneal fat (lipoma of the cord). If the mesh is anchored, staples or tacks are placed. If anchoring is not used, a large piece of mesh is placed with wide overlap of the hernia defect. The mesh crosses the midline and extends deep into the space of Retzius, widely overlaps the internal ring, covering the vas deferens and cord structures, and extends into the lateral inguinal space. The carbon dioxide gas is then released, taking care that the peritoneum does not snag and roll the mesh to displace it. The authors reinsufflate the peritoneal space, insert the laparoscope, and inspect for mesh placement and peritoneal defects. Even though these patients are under a general anesthetic, we spray local anesthetic into the extraperitoneal space and infiltrate all trocar sites with 0.5% bupivicaine with epinephrine. When the balloon dissector is used, a cutdown is made below the umbilicus and an incision is made through the fascia on the side of the hernia defect into the posterior rectus (preperitoneal) space, and the rectus muscle is retracted laterally to allow blunt dissection into that space. The balloon is then inserted and inflated in the preperitoneal space. Postoperative care After a stay in the recovery room, patients are observed for a short time in the outpatient postoperative area and most are released the same day of surgery. A mild analgesic such as propoxyfene/acetaminophen is prescribed. Patients are restricted from driving for 2 to 3 days until nearly pain free and off narcotic analgesics. They are encouraged to be up and about the same day of surgery and are allowed to bathe or shower the day after surgery. Their routine activities are not restricted. C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 1145 Fixation of mesh and use of balloon dissector Two issues mentioned above merit further attention: (1) fixation of the mesh with staples, and (2) use of a balloon dissector for the total extraperitoneal approach. Fixation or anchoring of the mesh to Cooper’s ligament, the pubic bone, and the transversalis fascia was standard practice when laparoscopic herniorrhaphy was introduced. Then, prompted by reports of persisting postoperative pain and nerve injuries from staples, some investigators advocated not fixing the mesh in place [11]. This idea was bolstered by Stoppa’s success with nonfixation of mesh in the open preperitoneal operation [12]. If a large enough piece of mesh is placed (at least 10 15 cm), with satisfactory overlap of the hernia defect, the increase in intraabdominal pressure at the end of the operation serves to hold the mesh in place, sandwiched between tissue layers. An interesting report from Britain [13] showed that when nonfixed mesh was marked with clips and abdominal films were performed at 1, 7, and 28 days, and 3 months after repair, mesh did not migrate appreciably. One retrospective study [14] and two randomized controlled trials [15,16] have shown no difference in recurrence rates for stapled versus nonstapled repairs. There was a trend to more neuralgia in one study in patients in whom staples were used [14]. The debate will continue and more investigation is needed to answer this question. The advantage of the balloon dissector is that it may make the TEP operation easier for the beginning surgeon and help him along the learning curve [17,18]. It may also cut the operating time for the beginning as well as the experienced surgeon. It costs more, however [17]. The balloon was used in a number of the randomized trials studying TEP versus open repair, but many investigators have performed dissection without the balloon. Few investigators have studied this question by itself and further study may be warranted. Randomized controlled trials, systematic reviews, and meta-analyses The last decade has witnessed enthusiastic investigation comparing laparoscopic hernia repair with open repair, as evidenced by the publication of four meta-analyses [19–22], two systematic reviews [23,24], nearly 70 randomized controlled trials, and numerous retrospective reviews. The retrospective reviews, as would be expected, mostly described the different laparoscopic repairs and presented data supporting the feasibility of the laparoscopic approach. That paved the way for prospective randomized trials, which have attempted to determine how the laparoscopic and open methods compare. The first of these was by Stoker et al from Great Britain, published in 1994 [25]. More recently, systematic reviews and meta-analyses have attempted to draw conclusions from the randomized trials. Our purpose in this section is to give an overview of the literature and guide the reader 1146 C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 through these studies to some meaningful, accurate, and reasonable conclusions. The randomized controlled trials are of varying quality. Many are poorly designed, are underpowered (small sample size), and are made up of heterogeneous control and study groups (open repairs including sutured as well as mesh repairs and laparoscopic repairs including TAPP, TEP, and onlay mesh). The difficulties these problems present in drawing conclusions should be obvious. The easily measured endpoints, such as hernia recurrence and operating time, are usually reported accurately, but more subjective endpoints, such as postoperative pain and return to normal activity and work, are not usually reported in a standard, quantified manner except in a few instances [26,27]. Operative cost, which would seem to be a concrete, easily measured outcome, is in fact, harder to measure than one might expect because of the many variables that are difficult to control and the issue of cost savings outside the hospital setting (the cost benefit of an earlier return to normal activities and work). Although difficult, it is possible to measure those costs, but it requires a well-designed study. In addition to these confounding factors, open hernia repair underwent an evolution during the 1990s from a predominantly sutured repair to a tension-free repair with mesh. That changed the question to be answered by hernia trials. Whereas the early trials compared laparoscopic repair with open sutured repair, it became more appropriate by the end of the decade to compare laparoscopic mesh repair with the open-mesh repair. Several large multicenter randomized trials are, for the most part, welldone and provide accurate data. They warrant mention because they form the backbone of the meta-analyses to be discussed later (Table 1). The European Union (EU) Hernia Trialists Collaboration [19,20] has not sponsored an independent study, but has organized the most extensive meta-analysis to date and continues to accrue data in an effort to refine its conclusions. Table 1 Hernia trial groups and large studies Group/Study Operations compared COALA Hernia Repair Trial [30] (Conventional Anterior versus Laparoscopic) Holland Laparoscopic Groin Hernia Trial Group [79] MRC (Medical Research Council) Britain SCUR Hernia Repair Study [80] Sweden EU hernia Trialists Collaboration [19,20] (70 surgeons, 20 countries) Berndsen, et al [81] Sweden Khoury [82] Canada Bringman, et al [83] Sweden TEP vs. open sutured TAPP/TEP vs. open mesh TAPP vs. open, preperitoneal Meta-analysis. Various types of repairs TAPP vs. Shouldice TEP vs. mesh-plug TEP vs. mesh-plug vs. Lichtenstein Abbreviation: COALA, conventional anterior laparoscopic. C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 1147 In regard to meta-analyses and systematic reviews, it should be mentioned that there are advantages and disadvantages to performing these studies. Meta-analyses are criticized for lumping together data from studies of disparate study design, populations, methodology, and statistical quality, therefore leading to invalid conclusions. If well-done, however, they can first, provide data for accurate conclusions because of the increased ‘‘statistical power of the analysis as well as the precision of the estimate of the treatment effects’’ [28], and second, provide information for the design of further studies. In addition, they have the practical advantage of combining and summarizing the results of numerous pertinent investigations into one paper so the practicing clinician does not have ‘‘to retrieve, evaluate and synthesize the results of all studies on the topic’’ [29]. Systematic reviews are less rigorous in their statistical analysis, but can provide a similar benefit. To their credit, the authors of the reviews and meta-analyses on laparoscopic herniorrhaphy have been careful not to overstate their conclusions. The first systematic review, by Cheek et al in 1998 [23], evaluated a variety of hernia studies, both retrospective and randomized prospective. Because of the heterogeneity of the groups studied, the diversity of study designs, and the generally poor methodological quality of the studies reviewed, conclusions were difficult to draw. This paper is most useful as a comprehensive review of the literature up to 1998 and as a guide for which open and laparoscopic studies to that date are of good quality. The first meta-analysis in 1999 by Chung and Rowland of Canada [21] included 14 randomized controlled trials. They combined data on operation length, postoperative pain, time to recovery, and hernia recurrence. Complications and costs were not addressed. Their statistical analysis was strong and their inclusion/exclusion criteria were clear and appeared to be followed closely by the reviewers. Their statistical analysis was strengthened by analyzing the data both with and without one of the large studies (a sensitivity analysis) [30] to see if the exclusion of those data effected the results. Exclusion of that study, which was 5 to 9 times as large as the smaller trials, made no difference in the results. Their conclusions were that the laparoscopic repair takes longer and costs more but that patients have less pain and return to work faster. Recurrence rates are similar. The meta-analysis by Voyles et al [22] deserves some attention, because although it is titled a meta-analysis, its statistical methods and reporting of data do not meet the criteria for a meta-analysis [28]. Under the heading of ‘‘Methods’’ no information is given on statistical analysis or how they addressed publication bias. In the ‘‘Results’’ section there are no tables of results for each study and there is no mention of negative findings, but merely a listing of P values, the source of which is not clear. There are no statistics on operative complications. Their conclusion, that an open hernia repair using a preperitoneal mesh prosthesis is ‘‘the optimal hernia repair’’ (which may actually be the case in many situations), does not seem directly supported by the data. 1148 C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 The most extensive systematic review [24] and meta-analysis [19,20] of randomized controlled trials so far are those produced by the EU Hernia Trialists Collaboration. This group is a consortium of 70 investigators from 20 countries whose purpose is to analyze data from randomized controlled trials and report it in meta-analysis form. Data from future studies are to be included and analyzed as they are published. The group’s systematic review of 2000 [24] identified 34 eligible trials. Recurrence data was accurate in most of the studies and as a consequence could be analyzed and reported in a meta-analysis format. Recurrence rates were not significantly different between the laparoscopic and open methods. Data on other endpoints (return to work, postoperative pain, and so forth) were either absent or so poorly reported that they could not be meta-analyzed. For their meta-analysis, reported in 2002 [19,20], the group was able to obtain individual patient data for 4165 patients in 25 trials and reanalyze it using meta-analysis methods. This was a marked improvement over their systematic review. Inclusion/exclusion criteria were excellent; there were two reviewers for each study and if there was disagreement on a point, a third reviewer arbitrated; and type of open hernia repair was controlled as best as possible by dividing the comparisons into the following categories: TAPP versus mesh TAPP versus nonmesh TAPP versus mixed open TEP versus mesh TEP versus nonmesh TEP versus mixed open This allowed comparison of more homogeneous groups. There was good statistical analysis of principal outcomes (recurrence, operative time). Fewer studies met the criteria to be included in analysis of persisting pain (lasting at least a year) and return to normal activities. Cost data were not analyzed. Data was reported in standardized meta-analysis format. The conclusions: (1) return to normal activity is faster after laparoscopic repair, (2) persistent pain is reduced after laparoscopic repair, and (3) the recurrence rate is lower for laparoscopic mesh repair versus open nonmesh repair but is the same for laparoscopic repair versus open-mesh repair. One large Swedish trial is unreported and recruitment to another in the United States is ongoing. It is uncertain whether the addition of these studies will result in new conclusions. Four issues not studied in depth in the above analyses should be mentioned because of their potential impact on the future of laparoscopic herniorrhaphy. The first of these is costs, which will be covered in a later section. The second is the laparoscopic repair of bilateral hernias and the third is the repair of recurrent hernias—two situations in which the laparoscopic approach may be advantageous. The fourth is the learning curve for laparoscopic herniorrhaphy. C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 1149 Laparoscopic repair of bilateral hernias makes sense because the patient has three small incisions instead of two large ones. Bilateral repairs received passing attention in early studies, which reported them as part of an analysis of unilateral hernia repair [31–34]. Subsequent investigators have focused on bilateral inguinal hernioplasty alone in both nonrandomized [35–38] and randomized [39] trials. Early results showed some high recurrence rates, but these may have been due to surgeon inexperience or mesh that was too small [32,37]. One recent large study of 1336 bilateral TAPP repairs, placing two pieces of mesh fixed to the structures of the myopectineal orifice, reported a recurrence rate of 0.6% with a median follow-up of 24 months (range, 1–84 months) [38]. The only randomized controlled trial investigating bilateral inguinal hernias compared the TAPP procedure (with placement of a single large ‘‘bikini mesh’’) with an open Lichtenstein repair [39]. The study was small (43 patients) but had no recurrences for the laparoscopic group. Results favored the laparoscopic repair for postoperative comfort and return to work. (Several authors have suggested that one advantage of laparoscopic repair is the ability to diagnose a clinically occult hernia on the contralateral side and repair it at the same time [40–42]. The incidence of unsuspected hernias was 20%–50% in these reports.) In summary, it appears that the laparoscopic repair of bilateral hernias is feasible and may be desirable. Laparoscopic repair of recurrent hernias, first operated on anteriorly, also seems to make intuitive sense. First, the surgeon is dissecting through virgin tissue instead of old scar, and second, it is argued by some that in repairing recurrent hernias, for which there is a high subsequent recurrence rate, one does not want to miss additional defects [43]. Therefore assessment of the entire myopectineal orifice is crucial. The laparoscopic repair can be done with low recurrence rates (0%–1.1%) [43–47], and several studies reported less pain and faster convalescence [44,48,49]. Other authors, however, have reported higher recurrence rates of 5% to 20% [50–52]. The only randomized controlled trial showed a 12.5% recurrence rate for the TAPP repair [52]. It appears that laparoscopic repair of recurrent hernias can be done safely and with few recurrences, but clearly further study is necessary to determine its effectiveness compared with open methods of repair. Lastly, the learning curve for both TAPP and TEP is well-recognized and its steepness has been a point of criticism from several quarters. Some investigators have addressed the subject and shown that as the surgeon becomes more experienced, operating times, conversions to an open procedure, complications, and recurrences all decrease [17,53–56]. It is not known precisely how many operations are required to attain proficiency, but 30 to 50 appears to be the range [17,54–56]. Recurrences What is the recurrence rate for laparoscopic inguinal herniorrhaphy and what are the reasons for recurrence? 1150 C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 As could be expected, before refinement of techniques and before much experience was gained, some early investigations reported high recurrence rates. Two early studies from 1994, one a multicenter review [57] and the other a single-institution review by Schultz [58], reported 22% and 26% recurrence rates respectively for the laparoscopic mesh plug technique. The TAPP and TEP repairs faired much better, with recurrence rates of 0.7% and 0.4% respectively [57]. A review of 23 noncomparative trails of laparoscopic hernioplasty from 1992 to 1995, all with 100 or more patients, showed recurrence rates ranging from 0% to 4.5% [50]. Fifteen of the 23 studies in that review followed their patients at least 1 year and 6 of them followed their patients for more than 2 years. This is felt to be adequate follow-up, as Stoppa showed that all of his recurrences using the open preperitoneal technique occurred within the first year and were thought to be due to technical error. As for the mechanisms of recurrence, these are listed by numerous authors [10,57,59–61] and are summarized in Box 1 below. They are almost all technical problems. As techniques have evolved and improved, recurrence rates have fallen. Likewise, as the technician (the surgeon), has improved, so have his results. The two most common causes of recurrence are incomplete dissection of the myopectineal orifice and inadequate size of the mesh. Lowham et al [10] reviewed 13 videotapes of hernias that had recurred in the multicenter trial by Fitzgibbons et al [62] and found that incomplete dissection of the myopectineal orifice was the primary cause of recurrence. There were other causes also, but in many cases they were secondary to inadequate dissection. It should be obvious that incomplete dissection leads to missed hernias (direct or indirect) as well as to missed lipomas (herniated preperitoneal fat). Lilly and Arregui [63], Gersin et al [64], and Felix et al [59] have all pointed out that a missed lipoma may be a significant factor in recurrence and should be searched for in every case. Absence of a peritoneal sac at laparoscopic inspection, especially during a TAPP repair, does not exclude a herniation of preperitoneal fat [64]. Inadequate reduction of a direct hernia sac and inadequate dissection of a proximal indirect sac from the spermatic cord also fall under the heading of incomplete dissection and should be attended to before placing the mesh. Rolling of the edges or corners of the mesh is a result of inadequate dissection, because a space too small to accommodate the mesh leads to mesh buckling and therefore rolling of the edges of the mesh. Small mesh leads to inadequate overlap of the defect—overlap should be at least 2 cm if mesh is stapled and 3 cm to 4 cm if not stapled. It also can result in migration of the mesh, and in some cases, rolling of the mesh [57,60,64]. Shrinkage of mesh is a recognized phenomenon and is a bigger problem the smaller the mesh [10]. The average prosthesis size in patients with recurrence was 6.5 cm 9.6 cm in the multicenter trial by Fitzgibbons et al [62]. Subsequent investigations showed that the mesh should be at least 10 cm 14 cm in cases where the mesh is fixed and 10 to 15 cm 15 cm C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 1151 Box 1. Causes of recurrence Evolution of technique Inexperience (learning curve) Incomplete dissection Missed hernia Missed lipoma (herniated preperitoneal fat) of cord or of direct hernia Inadequate reduction of direct hernia sac Inadequate dissection of proximal indirect sac from cord Rolling of mesh Mesh size and configuration Too small Inadequate overlap of defect Migration Configuration (slit or keyhole) Mesh fixation Mesh poorly fixed laterally Mesh poorly fixed medially Clips pulled through Mesh never stapled Issue of mesh fixation versus nonfixation Mesh displacement Hematoma Seroma Migration Rolling of mesh Shrinkage where the mesh is not fixed [31,65]. Some surgeons cut a slit or keyhole in the mesh to better fit the mesh around the gonadal vessels and vas, but this has been found to lead to herniation of the cut mesh through the internal ring or to herniation of preperitoneal fat if the slit is made too large. As mentioned earlier, fixation of the mesh is now a debatable issue, as at least two randomized controlled trials show no difference in recurrence rates for fixation versus nonfixation [15,16]. Other authors [10,57,59–62], however, focus on the lack of fixation or improper fixation as a major cause of recurrence and emphasize correct methods of fixation. (In some of these studies, recurrence may have been caused by the use of smaller mesh.) It appears that the vast majority of trials so far have used mesh fixation, but the question remains to be answered. Finally, displacement of mesh by a hematoma or seroma is mentioned by some as a cause of recurrence in a small number of patients. This may be due to technique (rough dissection or inadequate fixation of mesh) but may 1152 C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 also be one of the only factors that in some cases is out of the control of the surgeon (ie, patients with a coagulopathy, fragile tissues, bad luck). Complications Numerous authors have studied the complications of laparoscopic herniorrhaphy either as the primary focus of their analysis or as a major part of their investigation of laparoscopic hernia repair [38,57,62,66,67]. Complication rates vary from 3.8% to 13.6%. Some investigators divide their complication results into intraoperative and postoperative categories [57,62], or by the different types of repair (ie, TAPP, TEP, IPOM, plug and patch, ring closure) [57,66]. This has helped sort out where problems exist in the performance of a particular type of repair, and has helped determine which hernia repairs have unacceptably high recurrence or complication rates (laparoscopic plug and patch). Laparoscopic herniorrhaphy shares some complications with the open technique but also has its own set of complications. Some of these problems were encountered early on and were corrected as surgeons became more experienced with the technique. Thus, the incidence of complications has decreased with time [62,67]. In an interesting analysis of their experience, Felix et al found a 2.7% complication rate over a 6-year period, but when the data was broken down into two 3-year periods, their complication rate of 5.6% for the first 3 years dropped to 0.5% in the second 3 years. They also found that 90% of the complications occurred in the first 50% of patients [67]. In a similar vein, Fitzgibbons et al looked at postoperative neuralgia and found that leg pain decreased significantly (from 7% to 1.8%) after surgeons performed 30 cases. Postoperative groin pain remained steady at about 8% and testicular pain at 2% [62]. Complications from laparoscopic herniorrhaphy can be categorized into those that occur intraoperatively (Box 2 below) and those that occur postoperatively (Box 3 below). Complications related to the laparoscopic technique itself, or to the hernia repair, include vascular injuries or injuries to bowel. A number of early studies [19,20] showed a higher rate of these injuries, especially with the TAPP repair, but the incidence decreased with time and with a change in some centers to the TEP repair. Hypercapnia (and its related problems—subcutaneous emphysema, pneumomediastinum) is a complication of laparoscopy and is often out of the surgeon’s control. It is associated more with the extraperitoneal approach than with other approaches. Lower insufflation pressures may help prevent it. The majority of complications are postoperative. Urinary retention, a complication of open repair as well, was the most common of the patientrelated problems, with an incidence of 1.3% to 5.8% [57,62,66]. Tetik et al and others found a high incidence of hematomas and surmised that it was due to the more extensive dissection performed with the TAPP and TEP repairs [57]. Some, however, have found a lower incidence [19,20]. Chronic C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 1153 Box 2. Intraoperative complications Related to laparoscopic technique Trocar injury to bowel, bladder Trocar site hemorrhage Abdominal wall hematoma Hypercapnia Subcutaneous emphysema Pneumomediastinum Pneumothorax Related to laparoscopic hernia repair Vascular injury Femoral vessels Epigastric vessels Gonadal vessels Nerve entrapment (stapling, tacking) Transection of vas deferens Transection of nerve(s) groin pain or neuralgia, both of the ilioinguinal nerve and the lateral cutaneous nerve of the thigh, occurred with an incidence of 0.5% to 4.6% and depended on the technique of repair. The IPOM method had the highest incidence of neuralgia in one study [62], and that, among other reasons, led to its abandonment as a viable repair. As surgeons have become more knowledgeable of the nerve anatomy from the abdominal perspective, the incidence of neuralgia has decreased. Testicular problems include pain, swelling, and orchitis, and occur in 0.9% to 1.5% of cases. Most are transient. Orchitis was found in a small number of patients but did not lead to testicular atrophy [57,62,66]. Clinically significant trocar site hernias, leading to small-bowel obstruction and mesh complications, occurred early in the experience and have decreased in incidence. Likewise, as surgeons became more meticulous about peritoneal closure (in the TAPP repair) or switched to the extraperitoneal repair, the incidence of small-bowel obstruction from that etiology decreased. Phillips et al pointed out that to put these complication rates in perspective they must be compared with complication rates for open repairs. If that is done, one finds that the laparoscopic repair compares favorably with the open repair in a number of areas—vascular injuries, testicular problems, seromas, and hydrocele [66]. Notably, the EU Hernia Trialists meta-analysis found no difference in the complication rates of laparoscopic versus open repair [19,20]. Therefore, despite some early problems and complications unique to the operation, the laparoscopic repair has proven itself a safe procedure in the hands of experienced surgeons. 1154 C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 Box 3. Postoperative complications Related to the patient Urinary retention Others (MI, PE, DVT, etc.) Related to the hernia repair Seroma Hematoma Hydrocele Neuralgias Nerve entrapment (staple) Nerve injury Ilioinguinal Lateral cutaneous nerve Groin pain Early (transient) Late (chronic) Testicular problems Pain Swelling Orchitis Trocar site hernia with secondary: Small bowel obstruction Incarcerated omentum Small-bowel obstruction from peritoneal hole Wound infection Mesh complications Infection Late rejection Costs—laparoscopic versus open repair Cost analyses comparing laparoscopic with open techniques of hernia repair are difficult to design and sometimes hard to interpret. Nevertheless, in the current environment it is important to consider cost when deciding which herniorrhaphy to perform. As a consequence, cost studies are vital in providing that information to practitioners. There have been several strong studies to date and it is impossible to do justice here to the complexities of their cost calculations and analyses; however, it is possible to draw some general conclusions. First, it is necessary to discuss the difficulties in determining hospital costs for herniorrhaphy. Hammond and Arregui [68] point out that one is not only dealing with known, direct costs but also hidden, indirect costs (administrative, facility and equipment depreciation, and so forth), enigmatic hospital C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 1155 accounting practices, and arbitrarily marked up charges for disposable items. Rutkow writes about the breakdown of costs into fixed overhead (rent, salaries, equipment common to each operation) and soft overhead (‘‘throwaways’’ such as caps, gowns, gloves, sutures, mesh) [69]. Several investigators have addressed these issues with some success. In addition, they have attempted the complex task of calculating the cost to society, in days missed from productive work, to determine if the shorter recovery for laparoscopic repair is enough to compensate for its higher costs. The results, although widely divergent, seem to favor the laparoscopic repair, as shown in Table 2. Evaluation of cost analyses for hernia repair includes many issues, but the most important are: (1) the surgical technique used, especially for the open repair; (2) adequate sample size (400–500 patients), to reduce the influence of the many variables; (3) reporting of information on recurrences and the cost of repairing them; (4) methods for estimating costs; (5) if a multicenter trial, the method for controlling costs between centers; and (6) the surgeon’s experience with the technique. Of the studies focusing primarily on cost [70–77] the ones by Leim et al [70] and Wellwood et al [76] have the strongest methodology. However, Wellwood et al did not include recurrence data, which is important in determining ultimate cost, and Liem et al compared open sutured repair with laparoscopic repair, probably not the comparison most investigators would make today. That might have biased the study toward the open repair, as there would be no cost for mesh. However, their recurrence rate for the open repair was 6.1%, versus 3.5% for the laparoscopic repair, which probably made the laparoscopic repair less expensive in the long run because of the cost of repairing a recurrence. Dirksen et al [75] and the Medical Research Council trial [77] included surgeons with little experience (those with a minimum of only 10 laparoscopic repairs to their credit), which may have lengthened the operating time. Dirksen et al used the Bassini repair for the control group, in which there was a high early recurrence rate. They included cost data for the repair of recurrences, however. Heikkinen et al’s studies [72–74] were welldesigned but vastly underpowered (40–50 patients in each study). Kald et al’s study [71] had a larger sample size (200 patients), was prospective and Table 2 Societal cost comparisons Societal cost savings by procedure Study (year) Liem (1997) [70] Kald (1997) [71] Heikkinen (1997) [72] Heikkinen (1998) [73] Heikkinen (1998) [74] Dirksen (1998) [75] Laparoscopic $1364 $524 $649 $1156 $464 Open Types of repairs $106 TEP vs. Open sutured TAP vs. Shouldice TAPP vs. Lichtenstein TEP vs. Lichtenstein TAPP vs. Lichtenstein TAPP/TEP vs. open mesh 1156 C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 randomized, and had appropriate exclusions, but it used the Shouldice repair for its control group and reported a 3% recurrence rate for that group compared with no recurrences for the laparoscopic group. Despite the shortcomings of these studies, it is interesting to note the similarity in cost differences reported (Table 3). This difference, in most cases, is the cost of disposable equipment and longer operating time. Swanstrom has published one of the only detailed descriptions of a cost-cutting effort for laparoscopic herniorrhaphy [78]. His group looked at the cost of each component of a laparoscopic hernia repair and cut costs wherever possible. They eliminated unnecessary items (fixation staplers, dissection balloons), sought less expensive alternatives for necessary items (mesh, trocars, and instruments) and pursued ways of cutting operating time. Their results demonstrated ‘‘a steady decrease in the cost of the laparoscopic hernia repairs, approaching and, for the bilateral repairs, bettering, the costs for open mesh repairs’’ [78]. Our unpublished data lead to a similar conclusion. Add to this the steadily decreasing reimbursement to surgeons in America from Medicare over the last number of years and it becomes difficult to cover the cost of laparoscopic herniorrhaphy (or any operation). A number of Medicare patients (those over 65 years old) are good candidates for the laparoscopic repair, however, and efforts such as those of Swanstrom are needed to cut costs and make this operation a viable option for those patients. Summary So where do things stand in 2003? Laparoscopic herniorrhaphy appears to result in less postoperative pain (acute and chronic) and in a shorter convalescence and an earlier return to work, compared with the open repair. Table 3 Cost comparisons (laparoscopic vs. open) Study (year) Payne (1994) [26] Johansson (1999) [80] Tanphiphat (1998) [84] Liem (1997) [70] Kald (1997) [71] Heikkinen (1997) [72] Heikkinen (1998) [73] Heikkinen (1998) [74] Dirksen (1998) [75] Wellwood (1998) [76] Medical Research Council (2001) [77] Cost difference (more for lap.) $600 $830 $435 $400 $432 $483 $517 $457 $446 $300 $505 $480 Type of Repairs TAPP with disposables TAPP with disposables With reusables TAPP vs Bassini TEP vs. open sutured TAP vs. Shouldice TAPP vs. Lichtenstein TEP vs Lichtenstein TAPP vs Lichtenstein TAPP vs. Bassini TAP vs. Lichtenstein TAPP/TEP vs. mesh Included disposables C.J. Davis, M.E. Arregui / Surg Clin N Am 83 (2003) 1141–1161 1157 It can be performed safely and with a low recurrence rate. However, it takes longer to do, is more difficult to learn, and costs more, all reasons why it is not more commonly performed. Currently, laparoscopic herniorrhaphy accounts for 15% to 20% of hernia operations in America and around the world. Who can blame the surgeon in a community practice for opting for the open mesh repair, operating on familiar anatomy, and using familiar techniques? Nevertheless, with efforts to cut costs by eliminating disposable equipment and honing skills to decrease operating time, laparoscopic herniorrhaphy will probably continue to be a contender, especially for the younger patient who wants to return to work quickly and for patients with bilateral and recurrent hernias. It is arguable that surgeons should possess skill in both open and laparoscopic techniques and should know the indications for each—some hernias are best repaired laparoscopically. That said, laparoscopic herniorrhaphy will most likely be performed by those with a special interest and proficiency in the technique. At the least, the laparoscopic revolution and laparoscopic hernia repair have helped elevate the study of hernia anatomy and herniorrhaphy to a position it deserves and this has made us all better hernia surgeons. What was once the stepchild of general surgery now occupies a more prominent and respectable place. With the continuing efforts of dedicated, energetic investigators, we should continue to see advances in the safe and effective repair of this most common of surgical maladies. Acknowledgments We would like to thank Mr. Mark Smith, Clinical Statistician, St. Vincent Hospital and Health Services, for assistance with statistical analysis; Mrs. Cindy Oakes for manuscript preparation; and Louise Haas and Denise Rumschlag of the St. Vincent Hospital Library. References [1] Ger R. The laparoscopic management of groin hernias. Contemp Surg 1991;39(4):15–9. [2] Schultz L, Graber J, Pietrafitta J, et al. Laser laparoscopic herniorrhaphy: a clinical trial, preliminary results. 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