|Year : 2019 | Volume
| Issue : 4 | Page : 134-141
Comparison of totally extraperitoneal groin hernia repair with and without mesh fixation
Lubov Kupershlyak, Zvi Perry, Boris Kirshtein
Department of Surgery A, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel
|Date of Submission||25-Jun-2019|
|Date of Decision||13-Aug-2019|
|Date of Acceptance||14-Aug-2019|
|Date of Web Publication||22-Oct-2019|
Dr. Boris Kirshtein
Department of Surgery A, Soroka University Medical Center, P. O. Box 151, Beer-Sheva 64101
Source of Support: None, Conflict of Interest: None
INTRODUCTION: Since the introduction of the laparoscopic technique for tension-free inguinal hernia repair, various mesh fixation techniques have been adopted. The need for mesh fixation during the surgery is still under debate. We conducted our study to compare the outcomes of laparoscopic totally extraperitoneal (TEP) inguinal hernia repair with (MF) and without (NMF) mesh fixation.
PATIENTS AND METHODS: One hundred and fifty-seven patients underwent laparoscopic inguinal hernia repair without mesh fixation during 2010–2014. Of these, 113 (71.9%) agreed to participate in our trial, underwent physical examination, and filled out a questionnaire regarding their satisfaction with the surgery outcome. The data collected from medical records and results of the examination and the questionnaire were processed statistically and compared to the results of a previous study, which included patients who underwent TEP with mesh fixation.
RESULTS: Mean follow-up was about 3 years in both groups. Duration of procedure and length of hospital stay were shorter in the NMF group. Patients without mesh fixation had less pain and earlier return to work and physical activity. There was no significant difference in recurrence rate between NMF and MF groups (5.6% and 4.6%, respectively). The majority of recurrences in the MF group were among patients in whom a nonsplit mesh was used. Surgery satisfaction, however, was significantly higher in the MF group.
CONCLUSION: TEP without mesh fixation results in better surgical and postoperative outcome comparing with mesh fixation. Overall hernia recurrence rate was similar in patients with and without mesh fixation. Regular follow-up of at least 18 months is recommended to define true recurrence rate.
Keywords: Groin hernia, laparoscopy, mesh fixation
|How to cite this article:|
Kupershlyak L, Perry Z, Kirshtein B. Comparison of totally extraperitoneal groin hernia repair with and without mesh fixation. Int J Abdom Wall Hernia Surg 2019;2:134-41
| Introduction|| |
Inguinal hernia repair is one of the most common operations in the general surgical practice, with more than 800,000 procedures performed yearly in the USA alone. Open and laparoscopic techniques for inguinal hernia repair are in use nowadays, both use a prosthetic mesh to cover the defects in the abdominal wall and create a tension-free repair. However, the laparoscopic approach is becoming increasingly popular in later years, due to shorter hospital stay, quicker recovery, and better cosmetic results.
Laparoscopic approach, although possessing a steeper learning curve and being more challenging for a surgeon, is a safe and efficient method for inguinal hernia repair. Performed by an experienced surgeon, it results in less postoperative pain, shorter operative time and recovery period, earlier return to normal activity, lower recurrence rates, and better cosmetic results and cost-effectiveness, making it the preferred method for the repair of most types of groin hernias.,
Of the two methods used for laparoscopic inguinal hernia repair, transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP), the latter is probably a better choice, as it involves no entrance to the abdominal cavity and decreases the risk of intra-abdominal complications. Use of each technique depends on surgeon's preference and experience.,
It is a common practice among surgeons performing laparoscopic inguinal hernia repair to fix the mesh using staples, tacks, stitches, or glue. Tacks fixation results in postoperative pain and sometimes in neuralgia due to damage to the nerves. In addition, tackers are expensive, and their use significantly increases the operative cost. Nonfixed mesh might fold up or migrate in the extraperitoneal region in the early postoperation period, before tissue ingrowth, and cause discomfort, pain, and/or hernia recurrence.,,,,,, These concerns persist, although numerous studies have shown that limiting the number of tacks used, or omitting them altogether, does not lead to an increase in hernia recurrence rate.,,,,,, It has also been noted by several authors that an important reason for hernia recurrence is incomplete dissection of the preperitoneal space and placement of a too small mesh without covering all potential hernia defects.,,,
However, in most studies, the patients were followed for up to 2 years from the operation. The aim of this study was to evaluate and compare the outcomes of TEP inguinal hernia repair with (MF) and without (NMF) mesh fixation for a long follow-up time.
| Patients and Methods|| |
A retrospective review of TEP procedures without mesh fixation performed by a single surgeon (BK) at Soroka University Medical Center and Assuta Hospital, Beer-Sheva, Israel, between February 2010 and January 2014 was conducted. The study was approved by the Helsinki Committee. Patients were followed up routinely and examined at 1 week and 1, 3, 9, and 12 months after surgery and registered prospectively in the outpatient clinic database. All patients more than 1 year after surgery were invited for an additional visit during the study period between August 2013 and December 2015, during which they were examined for hernia recurrence and answered a questionnaire regarding groin and testicular pain, and their satisfaction with the procedure. Data collected included patients' demographics, hernia predisposition factors (physical work, benign prostatic hypertrophy [BPH], constipation), hernia types, length of surgery, types of mesh used, complications, and outcomes, including pain, recurrence rate, time to return to normal and physical activities, and patient's satisfaction. Recurrence rate was calculated per patient and per hernia repaired. Surgery satisfaction was assessed on a scale from 1 (very much satisfied) to 4 (not at all). Results were compared to our previous study of TEP with MF  using split and nonsplit mesh, in which mesh fixation was performed by nonabsorbable metal tackers in both groups. We compared the results of NMF to overall and separate different MF groups. Rank score on the Mann–Whitney test for the NMF group was used to define patients' satisfaction with surgery. Lower values designate higher levels of patient satisfaction (1–4). The Mann–Whitney (or Wilcoxon-Mann–Whitney) test is can be used for comparing the efficacy of two treatments in clinical trials. It is often presented as an alternative to a t-test when the data are not normally distributed. The test can detect differences in shape and spread as well as just differences in medians. When using this test, we do not really compare means/averages, but we really compare the ranking of each observation and thus mean rank does not relate to a true number but instead is a ranking number (i.e. that observation was the second highest observation, etc.). The only thing we can infer from the mean rank of a group that it is higher/lower than that of the other group and not anything else (because these are fictional numbers derived from ranking the observations).
All patients were admitted to the surgical department. Surgery was performed under general anesthesia. A small incision was done right to the umbilicus. Anterior sheath of rectus muscle was opened. Balloon was used to achieve preperitoneal space. Standard 10 mm Hasson trocar, two 5 mm trocars, and 45° scope were used during surgery. Hernia sac was dissected according to its location. Mesh was prepared and inserted through 10 mm trocar, spread in the preperitoneal space, and covered hernia defects without fixation. CO2 was deflated under the vision of mesh position until the absence of the space. Anterior sheath was closed by Vicryl 2/0. Slit Vypro II (Ethicon, J and J) and Microval (MicroVal, France) meshes were used during surgery. Vypro mesh is partially absorbable lightweight multifilament mesh composed of equal parts of nonabsorbable polypropylene and absorbable polyglactin. Microval is lightweight knitted polypropylene monofilament mesh with anatomical groin shape.
The information was coded and stored in a Microsoft Office Excel file and was transformed into the SPSS 21.0 software (SPSS, Chicago, IL). The data were first analyzed using descriptive statistics (using the appropriate central and distribution indices). Comparison between groups was performed using the Pearson's Chi-squared test for nominal variables and the Fisher's exact test for dichotomous variables (when applicable). Comparison of quantitative variables was done using the parametric t-test when appropriate, while for a-parametric tests, we used Mann–Whitney test. Correlations were measured using Pearson's correlation for parametric variables and Spearman's correlation for a-parametric variables. Statistical significance was considered when P < 0.05.
| Results|| |
One hundred and fifty-seven patients underwent 158 TEP inguinal hernia repairs without mesh fixation in the study period. Of these, 113 (71.9%) responded to our recall and were included in the study (107 males [94.7%] and 6 females [5.3%] with a mean age of 58.1 [range 21–84] years). One patient underwent separate TEP twice for contralateral hernias. Demographic data of the patients are summarized in [Table 1]. Of the nonresponding patients, 11 (7%) were unwilling to participate, 9 (6%) failed to arrive to scheduled appointments, 8 (5%) had moved abroad or to another city, 6 (4%) were unreachable by phone, 4 (2.5%) could not recall having the surgery at all, 3 (2%) had passed away, and 2 (1.3%) were mentally challenged and unable to participate in the study. Predisposing factors for hernia occurrence and increasing intraabdominal pressure such as BPH in 41 (36.3%), hard physical work in 26 (23%), constipation in 12 (10.6%), and prostatic cancer in 2 (1.8%) patients were found. Mean time of follow-up was 32.3 ± 15.4 months from the operation.
Forty-two patients (36.8%) had a previous surgery in the lower abdomen. There were 33 recurrent hernias in 31 (27.2%) patients after previous open groin hernia repair (29 unilateral and 2 bilateral). Four patients underwent contralateral TEP to the previously open or laparoscopic repair. Eighty-three (72.8%) patients had bilateral and 31 had unilateral hernias (20 right- and 11 left-sided). There were 20 direct, 88 indirect, and 87 combined direct and indirect hernias (in one patient with bilateral hernia the type was not recorded).
Split and contoured Vypro mesh 15 cm × 12 cm was used in 98 patients (174 [86%] hernias: 22 unilateral, 76 bilateral) and anatomical Microval lite mesh in 16 patients (23 [14%], hernias: nine unilateral, seven bilateral). Mean surgery time was 24.8 ± 7.2 min. An additional other abdominal wall hernia was repaired laparoscopically during the surgery in seven patients.
Sugery outcomes are presented in [Table 2]. Mean hospital stay was 1.06 days. Most patients (107 [93.9%]) were admitted for 1 day and 7 (6.1%) for 2 days.
Bladder injury was observed in a patient who underwent previous open prostatectomy. It was repaired by two layers of Vicryl sutures and Foley catheter insertion for 10 days. His postoperative course was uneventful; however, unilateral hernia recurrence was found 5 months later and repaired by conventional open technique.
Minor postoperative complications appeared in 17 cases (14.9%) and included scrotal hematomas in nine, urinary retention in three, hydrocele in one case, and abdominal wall hematoma and periumbilical wound infection in two cases each.
The average duration of postoperative pain was 4.5 ± 9.3 days. Testicular pain appeared in ten cases (8.8%) with a mean duration of 0.7 ± 3.3 weeks. Twenty-eight (24.8%) patients developed seromas that lasted on average 9.3 ± 14.8 weeks. In 2 cases (1.8%), aspiration of the seroma was necessary.
During last examination, eight patients (7%) reported groin pain upon exertion. One had a persistent groin pain, unrelated to physical effort and defined as postoperative neuralgia.
Hernia recurrence was found in 10 patients (8.7%) and 11 of 197 hernias (5.6%). There were 9 (4.6%) unilateral and 1 (1.0%) bilateral recurrences registered. Of these, there were two direct (1.8%), three indirect (2.6%), and four combined (3.5%) hernias during initial surgery. In one patient with recurrence, type of hernia was not recorded initially. Mean time of hernia recurrence was around 15 months from surgery. In six patients, recurrences were registered during regular follow-up period and four later. Seven recurrences appeared after using Vypro (4.0% of hernias repaired using this mesh) and 4 after using Microval mesh (17.4% of all hernias repaired by this type of mesh). There were seven (8.6%) patients with recurrences with risk factors for hernia occurrence before surgery and three (9.1%) without them. Multivariate analysis of hernia recurrence found that only two of the factors examined can statistically predict hernia recurrence – age of patient and type of mesh used in the procedure (use of nonsplit mesh raises chances of recurrence).
Four recurrences were repaired by open surgery using mesh, and five asymptomatic patients decided to remain under follow-up.
Ninety-two (80.7%) patients were highly satisfied with the surgery, 11 (9.6%) mostly satisfied, 4 (3.5%) not fully satisfied, and 7 (6.1%) stated they were completely dissatisfied with procedure [Table 3]. The mean rank for this variable on the Mann–Whitney test was 272.84.
Ninety-five (84.1%) patients would recommend this procedure to friends and relatives and 12 (10.6%) were not sure. Six (5.3%) patients would not recommend this procedure.
There was no difference between study populations compared with previous MF report. Comparison of results reveals significant difference in the location and type of the initial hernias (P = 0.002 and <0.001, respectively) with the prevalence of bilateral hernias in the MF versus NMF group (90% vs. 70%). Furthermore, the incidence of right-sided hernias was almost twice that of left-sided unilateral hernias, in the NMF group. No such difference was observed in the MF group and its subgroups.
Operating time was significantly longer for the MF group (P < 0.001) and according to the post hoc test in both subgroups of MF. Additional hernia was more commonly repaired during the same operation (P = 0.027) in the NMF group. Umbilical or femoral hernias were most frequently repaired in NMF group, while incisional hernia was the most common in the MF group.
Minor postoperative complications, except postoperative neuralgia, had not been recorded in the MF group. There was no statistically significant difference in rate of postoperative neuralgia between MF and NMF groups (1.3% vs. 0.9%, respectively, P = 0.058). Analysis of patients with neuralgia in the MF group found 2 (2.3%) in the split mesh and 3 (1%) in the nonsplit mesh subgroup.
There was no significant difference in recurrence rate between MF and NMF groups (4.6% and 5.6%, respectively). Significantly lower recurrence rate was seen in the MF split mesh subgroup compared to NMF group (1.3 vs. 5.6%, P = 0.023). The mean time of the hernia recurrence was about 15 months and was similar in MF and NMF groups. In the nonsplit mesh group, it was shortest – 7 months only; however, follow-up of the nonsplit group was shortest too. Postoperative pain duration tended to be shorter in the NMF group than in the MF group (average of 4.5 vs. 10.7 days), but this difference was not statistically significant (P = 0.07).
Return to regular and physical activity was significantly shorter in the NF group (P < 0.001), in which none of the patients reported more than a week until they returned to regular activity, and more than a month until return to physical work or exercise. A similar difference was identified in subgroups analysis.
Follow-up time was slightly longer in the MF group (40 vs. 32 months). The subgroups analysis found significantly shorter observational time (P < 0.001) of about 10 months in the split-mesh subgroup compared with NMF group, while patients in the nonsplit subgroup were followed for the longest time. Rank score on the Mann-Whitney test for the NMF group was 272.84, for the MF group 241.25 (239.44 in the split-mesh subgroup, 241.78 in the nonsplit-mesh subgroup). Overall satisfaction with the operation was higher in the MF group, with P < 0.001. Logically, more patients in the MF group would recommend this surgery to friends and relatives (94.5% compared to 84.2% in the NF group [P = 0.012]).
| Discussion|| |
Since the presentation of laparoscopic tension-free surgery for inguinal hernia repair, various techniques have been used to secure the mesh in place in order to prevent migration or folding of the mesh, which could lead to recurrence of the hernia or physical discomfort. These included sutures, metal tacks or staples, and various forms of glue. A trial by Berney and Yeo  and meta-analyses by Sajid et al. and Shah et al., comparing glue fixation to tack fixation of mesh in laparoscopic inguinal hernia repair, has shown the former to be at least as good as the latter in preventing recurrence, and possibly better when considering other complications such as chronic groin pain. Recurrence rate of 0.9% was reported in Berney and Yeo's trial. The two meta-analyses did not count recurrence rates due to insufficient statistical strength of the included trials, only a conclusion about there is no statistical difference between tacker and glue mesh fixation.
There is also a disagreement about the necessity of fixating the mesh at all. Many clinical trials were conducted in an attempt to resolve this issue, but a conclusion has not been reached. Trials conducted by Moreno-Egea et al. and Taylor et al. suggest limiting the use of tack fixation in laparoscopic inguinal hernia repair to specific cases such as large or direct bilateral hernias, whereas other studies ,,, state that tacker mesh fixation is unneeded at best and maybe harmful at worst. Two meta-analyses by Tam et al. and Sajid et al. second this statement, both stressing the need for a large, randomized case-control study to confirm these results. The recurrence rate ranges from none at all with time of follow-up of 12 and 22–44 months, respectively,, to 3.5% (mean follow-up 15.3 months). It is interesting to notice than in Khajanchee's et al., as well as in Taylor's et al. trials, more recurrences were observed in the mesh fixation group (5.9% and 0.2%, respectively) than in the nonfixation group (1.9% and 0%). On the other hand, Garg et al. and Moreno-Egea et al. only reported recurrence in hernias repaired without mesh fixation (0.2% and 2.7%, respectively), but there was not a statistically significant difference from the fixed mesh repair in any of them. We observed high recurrence rate in nonslit MF group. The same technique was used in all cases. However, this group included patients who were operated by three different surgeons in our early TEP experience. Insufficient tissue dissection during surgery may cause mesh uprolling and displacement results in hernia recurrence.
Guidelines of the International Endohernia Society (IEHS) for TAPP and TEP inguinal hernia repair in 2011 stated needs in mesh fixation in direct hernia more than 4 cm with mesh medial overlap more than 4 cm. The last European Hernia Society's guidelines from 2014 stated  that traumatic (nonabsorbable) fixation devices are mostly unnecessary in TEP repairs using heavyweight mesh, and should be avoided, except in specific cases such as large direct hernias. There is no mention of atraumatic fixation or lightweight mesh in relation to TEP repair at all. Update of guidelines of IEHS in 2015 strongly recommended mesh fixation during TEP in direct more than 3 cm and indirect hernia more than 3 cm (new Grade A recommendation).
Types of meshes used to cover the hernia defects, for the creation of tension-free repair, also vary greatly between different studies. Meshes used include anatomical three dimensional (3D),,, preshaped,, or simply rectangular, slit on one side , or not slit.,,, Misra et al. reported cutting the mesh according to hernia size. It does not seem that the mesh type is an important factor in the success of the surgery, since studies using the same type of mesh show a marked difference in their results. Size of mesh used is less varied, as most researchers stress the need of a large mesh to minimize recurrence of the hernia, since small mesh size and mesh shrinking potential are prone to hernia recurrence. Most surgeons stated using mesh size of 15 cm × 12 cm. We used two types of mesh: anatomical 3D Microval lite and split Vypro mesh.
In our study, the recurrence rate for TEP laparoscopic inguinal hernia repair without mesh fixation was 5.6% compared to 4.6% in the study with mesh fixation. On the other hand, patients in the MF slit mesh subgroup had significantly shorter mean follow-up of 24 months (much less for some), while in other groups recurrence was found about 15 months after surgery. Therefore, we may conclude that a follow-up for shorter period of time is not reliable for hernia recurrence, and this time frame should be taken into account in future studies. Thus, in this study, patients with nonfixed mesh had a statistically significant lower recurrence rate compared to the fixed-mesh group (7.9% vs. 10%, P < 0.05), when counted by patients, but nonsignificant when counted by number of hernias repaired. The highest recurrence rate of 17.4% was observed in patients with nonfixated Microval mesh, followed by 4.7% in nonsplit Vypro mesh fixated with tacks. The lowest recurrence rate was seen after using split Vypro mesh with and without mesh fixation (0.6% and 3.4%, respectively). Thus, we may assume that slit Vypro mesh is one of the best options resulting in lower recurrence. It may be due to better adhering ability and an additional anchoring point when wrapping around the cord and providing better mesh-tissue fixation and dividing power pressure to the tissue. On the other hand, the smaller size of Microval mesh (14 cm × 10 cm) and less experience with it as well as with a wider dissection of the cord structures (parietalization), which is absolutely necessary when using an unslitted mesh, may be causes of recurrence. We will continue using this mesh to acquire more experience in a larger patient group to define true recurrence rate. There is a variety of new meshes on the market, we will use them more often and compare results later.
The recurrence rate in our series (both fixated and nonfixated mesh) was noticeably higher than reported in literature, which is surprising, since all the procedures were done by surgeons with many years of experience. A possible reason for this might be a form of selection bias: almost 30% of patients who have undergone surgery during the period of the trial have refused to participate or were unable to do so, mainly because of moving to another city/country. Moreover, since people experiencing problems after a surgery are less likely to move away or refuse to see their operating surgeon, we may assume that in most of those nonparticipants, there were no recurrences of the hernia.
The time it takes the patient to return to work or normal activities of daily living is an important marker of the success of hernia repair, but not many researchers include this parameter in their trials. This may be due to the fact that most of those undergoing inguinal hernia repairs are older and are not working. Thus, return to work is of less importance in this category. Of the studies that do measure this parameter, there is a noticeable variation in the results. Garg et al. report mean time to return to work of 9.9 ± 3.3 days in the mesh fixation group and 7.6 ± 1.3 days for nonfixation. Messaris et al., who did not use mesh fixation at all, reported that all patients, including some professional athletes, were back to full activity no more than 2 weeks after the surgery. Tam et al. in their meta-analysis found the mean time to return to work to be 3.2 days for groups with mesh fixation and 2.9 days for nonfixation groups. Our patients returned to normal activities up to 1 week in NMF group and 2.6 weeks in MF group, while return to physical work was significantly quicker in NMF versus MF group (4 vs. 6.8 weeks). Our results are not significantly different from previous studies. There was no difference in incidence of postoperative neuralgia between MF and NMF patients. Patients in the slit MF subgroup had highest occurrence of postoperative pain. Prospectively collected data during patients' follow-up in NMF and the retrospective nature of our previous MF study can explain this difference.
Surgery time was significantly lower in patients of NMF group. This was mainly resulted by growing surgical experience. We started TEP with MF technique as a learning curve and followed by NMF due to proposed guidelines and procedure cost efficacy. Higher rate of minor postoperative complications in NMF group was related to prospective data gathering. Previous our study was fully retrospective, except final patient's examination and questionnaire included questions about postoperative period few years before.
Patient satisfaction with the procedure was higher in the MF than the NMF group, despite the better objective outcomes included postoperative groin and testicular pain in the NMF group. Here, again, we may only guess at the reason for such controversy. As surgery satisfaction is subjective patient measurement and decision, we can assume that the cause of this result may be lower initial expectations in the MF group, in which all the procedures were performed in a public university hospital, and people tend to expect less from public medical institutions than from private ones, or due to their personal impression from the operating surgeon and the student performing the research, or for some other reason. Otherwise, surgery satisfaction and recurrence rate are near similar in two groups. Hernia recurrence may be another reason for dissatisfaction.
| Conclusion|| |
TEP without mesh fixation results in better surgical and postoperative outcome comparing with mesh fixation. Overall hernia recurrence rate is similar in patients with and without mesh fixation. Regular follow-up of at least 18 months is recommended to define true recurrence rate.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]