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| ORIGINAL ARTICLE |
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| Ahead of print publication |
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A prospective cohort study in laparoscopic inguinal hernia repair: Mesh fixation versus nonfixation
Kavin Sugumar, Kunal Nandy, Sameer Rege, Aparna Deshpande
Department of Surgery, Seth G.S. Medical College and King Edward Memorial Hospital, Mumbai, Maharashtra, India
| Date of Submission | 22-Mar-2020 |
| Date of Decision | 06-May-2020 |
| Date of Acceptance | 29-Jun-2020 |
| Date of Web Publication | 11-Jun-2021 |
Correspondence Address:
Kavin Sugumar,
King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai 400012
India
 Source of Support: None, Conflict of Interest: None DOI: 10.4103/njs.NJS_30_20
Introduction and Aims: The need for mesh fixation in laparoscopic inguinal hernia repair is still controversial. Although mesh fixation is believed to prevent displacement of the mesh and decrease recurrence, it may be associated with more pain. Herein, we aim to study the effect of mesh fixation on postoperative outcomes. Materials and Methods: In this study, we intend to compare the outcomes of all patients admitted in two separate surgical units (AD and SR) at King Edward Memorial Hospital between January and December 2017, who were scheduled for laparoscopic hernia repair. Both the surgeons utilized identical technical steps during laparoscopic hernia repair, except whether mesh fixation was done or not. We compare postoperative pain score using the visual analog scale (VAS), analgesic use, quality of life (QoL), and recurrence between patients operated by these two surgeons (mesh fixation vs. non-mesh fixation cohort groups). Results: Of 50 operated patients, 25 patients underwent laparoscopic hernia repair with mesh fixation (AD), while the remaining did not (SR, n = 25). There was a significantly higher VAS pain score, more analgesic use, and more QoL impairment in the mesh-fixed group in the postoperative period (P < 0.05). Overall, there was no recurrence at a 6-month follow-up. Conclusion: Mesh fixation during hernia repair leads to increased postoperative pain with a higher analgesic need, delayed functional recovery, and no decreased recurrence. Thus, we recommend hernia repair without mesh fixation as an alternative to mesh fixation in patients with small size hernia <3 cm.
Keywords: Fixation, Inguinal hernia, laparoscopic hernia repair, postoperative pain, recurrence
| Introduction | |  |
Nearly 75% of patients presenting with abdominal wall hernia are diagnosed to have an inguinal hernia.[1] Males and females have a lifetime risk of 27% and 3%, respectively, to develop an inguinal hernia.[1] Elective surgery is the treatment of choice for adults with an inguinal hernia and is one of the most commonly performed surgical procedures worldwide.[1] Laparoscopic inguinal hernia repair was popularized first during the 1990s, which has grown with time to present day where approximately 15% of all inguinal hernias are repaired laparoscopically in a preperitoneal fashion in which the hernia defect is covered with a prosthetic mesh.[2],[3],[4],[5],[6]
The two approaches used include total extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) procedure. Both the above-mentioned techniques have identical steps including preperitoneal dissection, landmark identification, and mesh placement. For TAPP, in addition to the various steps, there is an additional need for peritoneum closure. Furthermore, the mesh can either be fixed to the Cooper's ligament and abdominal wall anterosuperiorly and laterally with spiral tacks, clips, or sutures, or can be left without fixation. The need for mesh fixation is controversial until now, yet few have suggested that mesh fixation is necessary to prevent displacement of mesh and recurrence of the hernia.[7] However, mesh fixation is believed to contribute to increased postoperative pain and nerve injury which is estimated to occur in 2% to 4% of laparoscopic inguinal hernia repairs. The most commonly injured neural plexus include the femoral branch of the genitofemoral nerve and the lateral cutaneous nerve of the thigh.[8] The decision of mesh fixation is usually based on the surgeon's preference and experience. However, it is recommended to fix the mesh in all patients undergoing TEP and TAPP who have large defects (L3 or M3 hernias) as per the guidelines by the European Hernia Society (EHS)[9] [Table 1].
At present, there are no clear guidelines for mesh fixation in laparoscopic repair of small inguinal hernias. There is a clear lack of data with respect to mesh fixation in laparoscopic inguinal hernia repair in the Indian literature. Theoretically, mesh fixation is associated with more postoperative pain but a reduced recurrence rate. The purpose of our study is to compare operative time, immediate postoperative pain, quality of life (QoL) impairment, and recurrence rate at a 6-month follow-up between patients undergoing laparoscopic inguinal hernia repair with or without mesh fixation.
| Materials and Methods | | |
This study was conducted as a prospective observational study between 2017 and 2018 in a tertiary care hospital following approval by the Institutional Review Board and with the written informed consent of all participants. All patients between 25 and 75 years of age who were diagnosed clinically with inguinal hernia and fit for laparoscopic hernia repair were enrolled in the study after taking informed consent. For patients with bilateral hernias, both sides were considered separately. Patients not consenting for enrollment, with large inguinal hernias (L3 or M3), and undergoing open hernia repair or converted from laparoscopic to open repair were excluded from the study.
In this study, we intend to compare the outcomes of all our patients admitted in two separate surgical units (AD and SR) at King Edward Memorial Hospital between January 2017 and December 2017, who were scheduled for laparoscopic hernia repair. Both the surgeons utilized identical technical steps during laparoscopic hernia repair, except mesh fixation as per their respective prior surgical outcomes and technical expertise. In addition, both of the surgeons were initially trained in advanced laparoscopic techniques at the same institution and had almost identical years of experience (nearly 10 years in minimally invasive surgery) and operated around 30–50 patients diagnosed with inguinal hernia annually using a laparoscopic approach. One of the surgeons (AD) performed mesh fixation on all patients, whereas the other surgeon (SR) did not employ fixation of the mesh. When used, the mesh was always fixed in place by the tacking method. The decision of performing either TEP or TAPP was based on the discretion of the operating surgeon based on contents in the hernial sac and scrotal extension. Patients with larger hernia contents and/or scrotal extension were operated by TAPP repair.[10] Hence, we compare the outcomes of consecutive patients operated by these two surgeons (AD and SR) which varied in technique by whether the mesh was fixed or not.
Patient demographic information including age, gender, race, history of smoking, diabetes mellitus, American Society of Anesthesiologists (ASA) class, and inguinal hernia classified by the European Hernia Society[11] [Table 2] was obtained. Details regarding the procedure including TEP/TAPP and whether mesh fixation was done were noted. The operative time was calculated from the time of port placement until the port removal. Time taken for mesh fixation was calculated from the time of mesh placement until the time of port removal. Patients were assessed for pain relief and analgesic use postoperatively using the visual analog scale (VAS) on postoperative day 0 (POD0), POD1, and at the time of discharge. After discharge, the pain was assessed based on the frequency of analgesic taken and degree of impairment of daily activity into mild/moderate/severe categories [Table 3]. Patients were followed up after 2 weeks of surgery for skin suture removal. Patients were booked for a clinic visit at 2–3-month intervals. At 6 months post surgery, recurrence was identified by detailed history and physical examination.
Statistical analysis
Power analysis was done to calculate an adequate sample size of 280 (with 140 in each group), but since the study period was 1 year with approximately 50 laparoscopic inguinal hernias operated annually at our hospital, the sample size of convenience was taken as 50. Data were recorded prospectively on a dedicated database (Microsoft Excel spreadsheet, Office). Statistical analysis was performed using IBM SPSS Statistics for Windows, version 25 (IBM Corp., Armonk, N.Y., USA). A comparison between continuous and categorical variables was done using Pearson Chi-square tests and t-tests, respectively. P < 0.05 was considered significant.
| Results | | |
Patient selection
A total of 55 consecutive patients who underwent laparoscopic inguinal hernia repair at King Edward Memorial Hospital in two separate surgical units/teams (AD and SR) in the Department of Surgery between January 2017 and December 2017 were enrolled in this study. Five patients were excluded from our study because they had large hernia defects (>M3 or > L3) in which mesh fixation is the standard of care. Among the consecutive 50 patients included in the study, 25 were admitted in the first surgical unit (AD) and underwent mesh fixation by AD (Group A), and the remaining 25 were admitted in the second surgical unit (SR) and had mesh placement without fixation by SR (Group B).
Patient characteristics
The baseline patient characteristics are shown in [Table 2]. Patients in both the groups were comparable in terms of age, gender, smoking history, diabetes mellitus history, ASA class, and classification of inguinal hernia according to EHS (P > 0.05). Of 25 patients in group A, 15 patients (60%) underwent TAPP and 10 patients (40%) underwent TEP. Of the 25 patients in Group B, 12 patients (48%) underwent TAPP and 13 (52%) patients underwent TEP. There was no difference in the type of procedure performed between the two groups (P = 0.71).
The mean intraoperative time in Group A (110.80 min) was longer than Group B (90.60 min) but not statistically significant (P = 0.09). The mean duration from mesh placement till port removal in Group A (19.80 min) was longer than Group B (14.40 min) which was statistically significant (P = 0.007). Pain scores were compared among Group A and Group B with the VAS. Pain score was noted on the day of surgery (POD0), the morning of POD1, at discharge, and at the time of suture removal. On POD0, the mean VAS pain score for the mesh-fixed group was 5.28 versus 4.36 in nonmesh-fixed group. On POD1, the mean VAS score for the mesh-fixed group was 4.25 versus 3.60 in the nonmesh-fixed group. The mean VAS score at the time of discharge was 4.25 in the mesh-fixed group compared to 3.48 in the nonmesh-fixed group. The mean VAS score at the time of suture removal was 2.79 in the mesh-fixed group versus 2.24 in the non-mesh-fixed group. Mesh fixation was associated with a higher VAS pain score at POD0 (P = 0.0001), POD1 (P = 0.001), discharge (P = 0.001), and suture removal (P = 0.025) [Table 4] and [Figure 1].
Analgesic usage for postoperative pain control on POD0, POD1, and after discharge is shown in [Table 5]. There was a statistically significant difference in analgesic utilization between the two groups at POD0 (0.001), POD1 (0.0001), and after discharge (P = 0.001). Paracetamol and tramadol were the most common regimens used for mesh-fixed group and paracetamol was the most common analgesic used for non-fixed group. On POD0, in the mesh-fixed group, 64% required two analgesics for pain control, 28% required one drug, and 8% required three drugs. In the nonmesh-fixed group, adequate pain control was achieved with one drug in 84% of the patients and 16% required two drugs for pain control. On POD1, in the mesh-fixed group, 68% required two analgesics for pain control, 20% required one drug, and 8% required three analgesics. In the nonmesh-fixed group, 96% required one drug and 4% required two drugs. After discharge, in the mesh-fixed group, 64% used two analgesics, 20% required one drug, and 16% required three drugs for pain relief, while in nonfixation group, 60% used a single drug and 40% used two drugs for pain relief. Among the 50 patients, one patient who underwent TAPP in the mesh fixation group had postoperative seroma that resolved spontaneously and three patients (two in mesh fixed and one patient in mesh nonfixation group) had urinary retention post surgery. Due to a very small proportion of postoperative complications, we did not analyze them as a separate outcome. | Table 5: Comparison of analgesic utilization at postoperative day 0, postoperative day 1, and after discharge
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Impairment of QoL until skin suture removal and from suture removal to 6 months post surgery is shown in [Table 6]. In Group A, 10 (40%) patients had mild, 15 (60%) had moderate, and none had severe impairment of QoL, whereas in Group B, all 25 (100%) of the patients had mild impairment of QoL till skin suture removal. Mesh fixation resulted in a significantly higher postoperative QoL impairment (P = 0.000002) until skin suture removal compared to the nonfixation group. From the skin suture removal to 6-month follow-up, all 25 patients of both the groups had mild QoL impairment (P = 1). There was no noted recurrence at 6-month follow-up after surgery.
After the study period, all patients were contacted through phone 2 years from the index surgery (May 2019) to assess whether patients had a recurrence of symptoms following surgery. We were able to reach 36 patients; 16 patients of mesh fixation group and 20 patients of mesh nonfixation group. None of these patients had any recurrence of symptoms.
| Discussion | | |
Our study provides a valuable addition to the available literature on mesh fixation for laparoscopic inguinal hernia repair. In our study, there was a shorter time duration from mesh placement to port removal, lower postoperative pain score, decreased analgesic need, and lower QoL impairment in the immediate postoperative period in the nonmesh-fixed group. Furthermore, there was no hernia recurrence observed in both the groups at the follow-up of 6 months post surgery. After 2 years of the index study, of those who responded, none had a recurrence of symptoms. Hence, mesh fixation did not provide any benefit of decreased recurrence at the cost of increased postoperative morbidity and delayed functional recovery.
In 2010, Tam et al. conducted a meta-analysis of randomized clinical trials looking at outcomes following TEP repair with and without mesh fixation and showed that mesh fixation is associated with greater operative time.[12] A shorter operative time is known to decrease postoperative complications with a 14% increase in likelihood of morbidity with prolongation in intraoperative time by 30 min.[13] This is also corroborated by the study by Tam et al. where they show that the patients who did not undergo mesh fixation had a shorter length of stay. Our study showed a similar result. With the advent of outpatient surgery in many fields of surgery including minimal access surgery, it would make sense to shorten the operative time, and in turn, enable earlier discharge of patients.
In 2003, Lau and Patil conducted a case-control study comparing endoscopic TEP inguinal hernia repair with and without mesh fixation and found that postoperative pain levels upon coughing were decreased in patients when the mesh was not fixed; however, the difference was not statistically significant. Postoperative pain scores at rest from the day of operation to POD6 were comparable between the two groups of patients.[14] Other studies had similar results.[15],[16],[17],[18] However, the main drawback of these studies was the relatively short follow-up period. Above all, these studies frequently did not specify the dimensions of the hernial defect. Contradictory to previous results, a randomized clinical trial by Taylor et al. showed that TEP with mesh fixation resulted in chronic pain compared to nonfixation.[19] This study also concluded that >6 tacks result in postoperative pain. In our study, laparoscopic inguinal hernia repair in the mesh-fixed group was associated with a higher pain score postoperatively compared to the nonmesh-fixed group. Inadvertent stapling of nerves during TEP or TAPP leads to nerve entrapment and meralgia paresthetica, leading to postoperative pain.[20] Hence, by not fixing the mesh, we may decrease the chance of nerve entrapment which is one of the main reasons for postoperative pain.
A study by Koch et al. showed that mesh fixation is associated with more analgesic use.[15] A meta-analysis showed a trend toward higher analgesic use in mesh-fixed group, but the results were nonsignificant.[12] Our study showed that patients with nonfixation had lesser analgesic need. This reflects the decreased postoperative pain in this group, which, in turn, could translate to early recovery. Even though previous studies looked at time duration between surgery and initiation of normal activity, none looked at QoL impairment post surgery. Mesh fixation did not change the duration of normal functional activity.[12],[15],[18] We showed a greater QoL impairment in patients with mesh fixation. This could be directly attributed to the increased pain and greater analgesic use after mesh fixation.
The necessity of mesh fixation to prevent hernia recurrence following laparoscopic hernia repair for small-sized hernias is still controversial. Ferzli et al. conducted a randomized, prospective study comparing laparoscopic TEP inguinal hernia repair with and without fixation of mesh and similarly found no increase in the recurrence rate with nonfixation of the mesh.[18] Khajanchee et al. conducted a retrospective review of 172 endoscopic inguinal hernia repairs, of which 105 were performed with fixation of the mesh and 67 were performed without mesh fixation. They found no increased risk of recurrence in the group with nonfixed mesh, and fixing the mesh was associated with an increased risk of neuropathic complications.[21] Similar results have been noted in other studies.[12],[15],[16],[17],[19] This study is in concordance with both the above-mentioned studies.
A few multi-center studies have been performed to identify the mechanisms of hernia recurrence after laparoscopic hernioplasty.[22],[23] Inadequate fixation of the mesh, particularly at the lower medial corner, was found to be a common cause for the recurrence of inguinal hernia.[20] Phillips et al. recommended using the largest possible piece of mesh and fixing it securely.[23] Lowham et al. suggested that all small prostheses (<12 cm × 12 cm) required fixation to the Cooper ligament, the transversus abdominis aponeurosis, and the anterior lateral abdominal wall.[22] Tucker et al. considered adequate fixation of the mesh critical in preventing early recurrence.[24] Hernia recurrence can result from a combination of factors, including mesh migration, invagination or folding, hematoma or seroma formation, shear force during movement, the disruptive force from elevated intra-abdominal pressure, the use of a small mesh, and inadequate mesh fixation. Hollinsky and Hollinsky reported that for small hernias <4 cm, a minimum overlap of 3 cm should be achieved between the edge of the mesh and that of the hernial opening.[25] Otherwise, the mesh must be fixed to enhance the bursting strength of the repair and to prevent subsequent mesh migration. Accurate measurement of the longitudinal and transverse dimensions of the hernial opening is therefore pivotal to intraoperative decision-making on fixation. Proper documentation of the hernial dimensions also helps to evaluate its effect on the long-term recurrence rate.
In addition to the above outcomes assessed, prior studies have shown decreased cost-effectiveness in patients with mesh fixation. Ferzli et al. showed that mesh fixation resulted in a 120$ (USD) increase in material costs.[18] Taylor et al. showed a similar increase of 375$ (Australian dollar) with mesh fixation.[19] Similar results have been corroborated by Moreno-Egea et al.[16] In developing countries, such costs could not be afforded by most patients. Hence, by avoiding mesh fixation in patients with an inguinal orifice lesser than 3 cm, we hasten post operative recovery with the combined benefit of reduced cost.
| Conclusion | | |
A sound surgical judgment with an appropriate selection of the mesh size and the use of stapling determines the success of laparoscopic inguinal hernia repair. At present, there is a lot of controversies over the fixation of the hernia mesh during surgery. From this study, we recommend a laparoscopic inguinal hernia repair without mesh fixation as an alternative to mesh fixation in a select group of patients. We believe for small hernia (<3 cm), there is no advantage of mesh fixation as it rather leads to increased postoperative pain with an increased requirement of analgesia and no increased recurrence.
Limitations
Although our study provided a detailed analysis of surgical outcomes following laparoscopic inguinal hernia repair, it had few limitations. The study participants were not randomized into different groups. Even though both the surgeons were trained in the same institution, had similar surgical experience in laparoscopic surgery, and almost performed a uniformly similar number of operations annually, there is still a chance of bias in our results. Both the techniques of laparoscopic repair (TEP and TAPP) were included in the study and could be a cause of bias. A longer follow-up period will be needed to further consider the incidence of recurrence.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]
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