Literature DB >> 27073309

A prospective randomised controlled trial comparing chronic groin pain and quality of life in lightweight versus heavyweight polypropylene mesh in laparoscopic inguinal hernia repair.

Pradeep Prakash1, Virinder Kumar Bansal1, Mahesh Chandra Misra1, Divya Babu1, Rajesh Sagar2, Asuri Krishna3, Subodh Kumar1, Vimi Rewari4, Rajeshwari Subramaniam4.   

Abstract

BACKGROUND: The aim of our study was to compare chronic groin pain and quality of life (QOL) after laparoscopic lightweight (LW) and heavyweight (HW) mesh repair for groin hernia.
MATERIALS AND METHODS: One hundred and forty adult patients with uncomplicated inguinal hernia were randomised into HW mesh group or LW mesh group. Return to activity, chronic groin pain and recurrence rates were assessed. Short form-36 v2 health survey was used for QOL analysis.
RESULTS: One hundred and thirty-one completed follow-up of 3 months, 66 in HW mesh group and 65 in LW mesh group. Early post-operative convalescence was better in LW mesh group in terms of early return to walking (P = 0.01) and driving (P = 0.05). The incidence of early post-operative pain, chronic groin pain and QOL and recurrences were comparable.
CONCLUSION: Outcomes following laparoscopic inguinal hernia repair using HW and LW mesh are comparable in the short-term as well as long-term.

Entities:  

Keywords:  Chronic groin pain; heavyweight mesh; lightweight mesh; quality of life; totally extra-peritoneal/trans abdominal pre-peritoneal repair

Year:  2016        PMID: 27073309      PMCID: PMC4810950          DOI: 10.4103/0972-9941.170018

Source DB:  PubMed          Journal:  J Minim Access Surg        ISSN: 1998-3921            Impact factor:   1.407


INTRODUCTION

Inguinal hernia repair is one of the most common elective operations performed in general surgery.[12] Tension-free mesh based repairs are the most common method of inguinal hernia repair today, whether done by open method or laparoscopic because meshes have been shown to reduce the recurrence rates by up to 50%.[3] The most common open repair performed is the Lichtenstein repair.[45] Laparoscopic repairs can be done by two main approaches: Trans abdominal pre-peritoneal (TAPP) and totally extra-peritoneal (TEP). Laparoscopic repair of inguinal hernia has several advantages over open repair like less post-operative pain and morbidity, early recovery, rapid return to work and usual activities, low recurrence rate and better quality of life (QOL).[678] Efficacy of the mesh repair is based on strengthening of weakened native tissue by a strong mesh aponeurotic scar tissue (MAST) complex.[9] Inflammatory processes beyond the optimum foreign body reaction may entrap the contiguous structures leading to complications such as chronic groin pain.[1011] In the early and mid-1990s, increasing number of case reports reporting mesh related complications after conventional polypropylene mesh based hernia repair, prompted the investigators to develop better meshes. As a consequence, today two major mesh concepts are distinguished, the classical concept of heavyweight (HW) meshes having small pores (<1 mm), high tensile strength and a larger surface area and the lightweight (LW) meshes having larger pores (>1 mm), and high flexibility.[1213] Lightweight meshes are supposed to have many advantages over HW meshes like decreased incidence of chronic groin pain, early return to work and better patient comfort.[14151617] But most of the studies are small studies with very short follow-up. In recent years, attempts to evaluate the outcome of different health care interventions have increased dramatically. Patient-centred measures of outcome, measuring QOL after various interventions, have been developed and advocated for use in evaluation of treatment efficiency.[181920] The short form 36 (SF 36) is a popular health status measure. It is a 36-item questionnaire, which measure eight dimensions of health on multi-item scales. There is some literature to suggest that LW mesh implantation in inguinal hernia repair provides better QOL.[141516] There are very few small comparative and randomised studies comparing HW and LW meshes with ambiguous results. This study was conducted as a prospective randomised controlled trial to compare and evaluate the factors related to chronic groin pain and QOL after LW and HW mesh placement in laparoscopic inguinal hernia repair (LIHR).

MATERIALS AND METHODS

The study was conducted as a single centre prospective two arm single blinded randomised controlled trial in a single surgical unit at a tertiary-care referral hospital from February 2010 to January 2012. The study was approved by the Institute Ethics Committee and registered in the Clinical Trial Registry of India (CTRI/2012/09/002970, www.ctri.nic.in). A sample size of 140 patients was calculated using STATA version 11 (Microsoft) for windows to detect the changes over period of time in pain scores assuming that there are 5 post-operative follow-ups, considering the average incidence of the primary outcome measure, chronic groin pain at the end of 1st year in HW mesh group at 0.16 ± 0.5 and in LW mesh group is 0.04 ± 0.16,[7] expected dropout rate of 5% to ensure a power of 80% and α = 5% (significance level 95%). Patients who gave written consent for participation were randomised. Patients who refused consent were excluded from the study and the reasons for their refusal were noted. Randomisation was done using computer generated random numbers using NQuery version 1.0 (Microsoft) for Windows and then placed in sealed envelopes to ensure concealed allocation into two equal groups. The patients were randomised into two groups, LIHR using HW mesh (HW Mesh — Group I) or LIHR using LW mesh (LW Mesh — Group II). The study was conducted as a single blinded study with the participant not knowing the type of mesh placed. Inclusion criteria: Age 18-60 years. Simple uncomplicated inguinal hernia. Unilateral or bilateral. American Society of Anaesthesiologists grade I/II. Exclusion criteria: Age <18 years and >60 years. Significant co morbidities making patient unfit for general anaesthesia. Previous surgery to inguinoscrotal region. Obstructed/strangulated inguinal hernia.

Primary outcome measures

Primary outcome was taken as the incidence of chronic groin pain and QOL 3 months post-surgery

Secondary outcome measures

Operative time, ease of mesh deployment. Complications like wound infection, hematoma, seroma, neuralgia, numbness and other important events in the post-procedure period. Recurrence rates during a follow-up of 12 months. The demographic profile of the patients like age, sex, weight, height, body mass index and occupation were recorded on a pre-structured proforma. The detailed history and clinical features were recorded. A single dose of injection amoxicillin 1000 mg and clavulanic acid 250 mg after the skin test was given intravenously as prophylaxis at the time of induction. The second dose of prophylactic antibiotic was given 6-8 h after surgery. A 14-Fr Foley catheter was inserted after induction of general anaesthesia in all patients. All the patients underwent LIHR by either TAPP or TEP method. The standard method for dissection of sac and mesh placement for either technique was used.[21] No mesh fixation was used in either group. The HW mesh used in this study was a pre-shaped polypropylene mesh having weight of 80-85 g/m2, pore size of <1 mm and size 10.8 cm × 16 cm (three-dimensional [3D] max large, bard). The LW mesh used was a LW polypropylene mesh having weight of 30-45 g/m2, pore size of >2 mm and size 10 cm × 15 cm (Prolene Soft, Ethicon). A note was made for the intra-operative details, operative time, and complications. QOL was assessed in all patients pre-operatively and at 3 months post-operative follow-up. SF-36 version 2 questionnaire was used for QOL assessment. Permission was obtained from quality metric health survey to use SF 36 version 2 (SF-36 v2) in the current study.

Pain management and assessment

For post-operative pain relief in all patients, diclofenac sodium 75 mg was injected intramuscularly every 8 hourly for the 1st day. The patients were then placed on oral analgesia with a combination of paracetamol 500 mg with ibuprofen 400 mg every 8 hourly. The patients were discharged with advice of oral analgesics as described above 8 hourly for the first 2 days and to be taken on need basis after that. Pain was recorded in the immediate post-operative period at 6 h and 24 h and during follow-up at 1-week, 6 weeks, 3, 6 and 12 months during which time the analgesic requirement was also noted. Visual analogue scale (VAS) was introduced for recording pain pre-operatively in all patients. Follow-up was done at 1-week, 6 weeks, 3, 6 and 12 months in the follow-up clinic (FUC) of our unit. All patients in FUC were assessed and asked about their complaints and then examined for the presence of wound infection, hematoma, seroma, neuralgia, numbness, and recurrence. Patients with wound infections were advised for frequent follow-up for dressing and given antibiotics according to culture sensitivity. Patients with seroma formation were advised to follow-up after 4 weeks and then reassessed and aspirated if there was no improvement. Neuralgia and numbness were recorded at every visit. Patients were examined for recurrence at every visit. All patients were asked for the resumption of walking freely in the house, resumption of driving vehicles, and resumption of their work in post-operative period.

Statistical analysis

Data were analysed using SPSS version 15 Large 3DMax™ Mesh (BARD, Davol inc.) for windows and the techniques applied were Student's t-test/Mann-Whitney test wherever required to compare the continuous data in two groups. The categorical data was analysed using Chi-square test or Fisher exact test. The QOL scores were analysed via ANCOVA model. The change over period was seen by applying repeated measure analysis followed by post-hoc comparison by least square deviation method, separately for each group. P < 0.05 was considered as significant.

RESULTS

A total of 247 patients were screened for this study. Totally, 107 patients were excluded because of various reasons [CONSORT diagram, Table 1]. A total of 140 patients were randomised with 70 patients in each group. There were no pre-maturely opened envelopes. One patient in HW mesh group and two patients in LW mesh group were excluded because the mesh was fixed due to detection of large defect intra-operatively (protocol violation). A total of 131 patients completed a minimum of 3 months follow-up period, 66 in HW mesh group and 65 in LW mesh group and only these patients were analysed.
Table 1

CONSORT diagram

CONSORT diagram

Primary end points

There was no statistically significant difference between the two groups in the incidence of chronic groin pain at 3, 6 and 12 months [Table 4]. The incidence of moderate to severe chronic groin pain (which was taken as a VAS score ≥3) was 3% (2 patients) in both HW and LW mesh group. The overall incidence of chronic groin pain at 3 months was 21.3%, which decreased to 9.9% at 6 months and to 2.3% at 12 months. The analgesic requirement was also comparable between the two groups with both requiring comparable doses of analgesics in the follow-up period [Table 4].
Table 4

Comparison of return to activities between HW mesh and LW mesh groups

Comparison of return to activities between HW mesh and LW mesh groups All patients showed significant improvement in QOL from pre-operative to post-operative at 3 months. However, there was no difference in improvement of QOL scores when compared between the two groups in any of the domains [Figure 1].
Figure 1

Comparison of post-operative short form-36 health dimensions between heavyweight and lightweight mesh groups

Comparison of post-operative short form-36 health dimensions between heavyweight and lightweight mesh groups

Secondary end points

The demographic and clinical profiles of the two groups were comparable [Table 2]. A total of 175 hernia repairs were done in the study. TEP repair was performed in 69 (52.7%) patients and TAPP repair was performed in 59 (45%) patients, which was comparable in both groups. Three cases were converted from TEP to TAPP; two in HW mesh group and one in LW mesh group. The reason for conversion was loss of space due to major peritoneal tear in two patients and difficulty in creation of space due to dense adhesions in one patient. There was no conversion to open repair.
Table 2

Comparison of demographic profile and intraoperative findings between HW mesh and LW mesh groups

Comparison of demographic profile and intraoperative findings between HW mesh and LW mesh groups The mean operative time in LW mesh group was higher than in HW mesh group, but it was not statistically significant (60.2 ± 13.3 min vs. 57.3 ± 13.8 min, P = 0.22). The operative time in LW mesh group was higher than in HW mesh group for both bilateral as well as unilateral inguinal hernias, but it was not significant statistically. The other intraoperative variables were comparable in both the groups [Table 2]. In one patient in LW mesh group, there was an undetected urinary bladder injury during TAPP repair. The patient presented on post-operative day 1 with complaints of scrotal swelling. The patient was readmitted and catheterised. The swelling slowly decreased by post-operative day 3, and he was discharged with urinary catheter in situ. A retrograde urethrography and micturating cystourethrography were done 14 days later, which did not show any contrast extravasation from bladder. He did not require any further intervention over 12 months of follow-up. The mean post-operative hospital stay was 1.05 ± 0.2 days, and there was no significant difference in hospital stay between the two groups (P = 0.24). The mean pre-operative pain score in HW mesh group was 0.5 ± 0.7 and 0.6 ± 0.8 in LW mesh group (P = 0.7). There was no difference in the average pain score on VAS, at 6 h and 24 h and 1-week after surgery between the two groups [Table 3]. Totally, 10 patients in HW mesh group and 8 patients in LW mesh group required additional doses of analgesia and the analgesic requirement was comparable in both the groups [Table 3].
Table 3

Comparison of post-operative pain scores between HW mesh and LW mesh groups

Comparison of post-operative pain scores between HW mesh and LW mesh groups Two (1.5%) patients developed superficial port site (12 mm) infections at 1-week follow-up. Both the patients were from Group I. Both the patients were managed with daily dressing and antibiotics on outpatient basis. Both patients improved over a period of 5-7 days. In none of the patients, mesh had to be removed because of mesh related infections. Patients in HW mesh group took significantly longer time to return to walking freely (2.1 ± 0.6 vs. 1.7 ± 0.7, P = 0.002) and return to driving vehicles (20.8 ± 5.2 vs. 19 ± 6.7, P = 0.05). Although the time to return to work was also longer in HW mesh group, but it was not statistically significant [Table 4]. One young patient in HW mesh group had moderate pain and was not able to do his duties and had to take leave for 2 months. The mean follow-up was 10.1 months for HW mesh group and 9.8 months for LW mesh group (P = 0.6). There was no difference in the incidence of cord oedema and ecchymosis was comparable in both groups. The incidence of seroma formation was more in HW mesh group as compared to LW mesh group but it was statistically not significant (P = 0.6). A total of 16 (12.2%) patients had seroma at the first follow-up at 1-week, 9 (13.5%) patients in HW group and 7 (10.8%) in LW group. All patients were followed-up after 4 weeks, at which time they were reassessed and the seroma was found to be in a resolving state in most of the patients except one patient in HW and two patients in LW group. One patient in-Group II required single time aspiration. None of the patients had a residual seroma at 3 months follow-up. The incidence of numbness and testicular pain was also comparable between the two groups [Table 5].
Table 5

Comparison of complications between HW mesh and LW mesh groups

Comparison of complications between HW mesh and LW mesh groups Foreign body sensation was reported by 24 (18.3%) patients at 3 months follow-up. The incidence was less in patients in LW mesh group (15.4%) as compared to HW mesh group (21.2%). However, the difference was not significant (P = 0.38). There was one recurrence (1.5%) in LW mesh group at 2 months after surgery. The patient had undergone a TAPP repair with LW mesh for left incomplete indirect inguinal hernia. He was taken up for a left TAPP repair for recurrent hernia. Intra-operatively the anatomy could not be delineated due to dense adhesions. So the procedure was converted to open. The mesh was found to be displaced and herniated through the dilated internal ring and forming part of the sac. The sac was dissected; mesh was removed and mesh repair done using a Prolene hernia system®. There was no recurrence in HW mesh group over a mean follow-up of 10.1 ± 3.7 months.

Heavyweight versus lightweight mesh in totally extra-peritoneal and trans abdominal pre-peritoneal repair

The difference between HW and LW mesh in TEP repair, and TAPP repair was also compared. No difference in mean VAS scores at any time between the two groups was observed in both TEP and TAPP. Return to walking, return to driving vehicles and return to work was significantly earlier in LW mesh group in TEP repair. However, no difference was seen after TAPP repair in these parameters between the two groups.

DISCUSSION

Groin hernia repair is a one of the most common operations performed by a general surgeon.[12] The principle that tissue-based repair, at its root, is based on some tension between tissue layers and thus at risk of recurrence led to the use of mesh to perform a tension-free repair of the hernia defect.[3] The efficacy of the mesh repair is based upon strengthening of weakened native tissue by a strong MAST complex which is an infiammatory response induced by the mesh material.[4] The persistence of this infiammatory response after formation of MAST complex has been a cause for concern because it leads to long-term problems like chronic groin pain, foreign body sensation and nerve entrapment leading to neuralgia and other symptoms.[5] This prompted the researchers to investigate the biocompatibility of two different mesh modifications; HW meshes having small pores and the LW meshes having larger pores.[6] There have been few studies in the literature, which have shown the efficacy and superiority of LW mesh over conventional HW polypropylene mesh.[7] However, efficacy and safety of the LW meshes has not been studied in detail and whether the LW meshes help in reduction of the long-term mesh related problems by decreasing the inflammatory response remains questionable. Few studies have also raised concerns about increased risk of mesh displacement and recurrence with the use of LW mesh due to soft texture and tendency of these meshes to fold easily.[89] Various studies have also reported a longer operative time in LW mesh group due to difficulty in laying out the mesh as it has a soft texture with a tendency to get folded easily.[91011] In our study, although the mean operative time was 3.7 min longer in the LW mesh group, the difference was not statistically significant (P = 0.09). The cost-effectiveness of any procedure is important because healthcare resources are scarce, and they must be allocated judiciously. Not many studies in literature have compared the cost-effectiveness of LW and HW meshes. Chui et al.[12] mentioned that in their study that the mean cost that incurred to the patient in LW mesh group was higher. The cost of LW mesh (Dynamesh) used by them was 6 times higher than the HW mesh (Surgipro). However, in our study, the total cost was significantly less in LW mesh group as compared to HW mesh group. This is because we used Prolene Soft (Ethicon®) as the LW mesh, which is costlier than the conventional Prolene mesh but cheaper than the pre-shaped 3D max mesh (Bard®) which was used as the HW mesh in this study. Studies have also reported decreased early post-operative pain in LW mesh group because of less acute inflammatory response.[79] In our study, the mean pain score was comparable between the two groups at 6 h, 24 h and 1-week post-operatively. However, the mean VAS score was significantly higher in patients in LW mesh group in TAPP repair at 1-week while the mean VAS score was comparable between the two groups in TEP repair at same follow-up visit. This may be because of the increased pain associated with TAPP as compared to TEP repair, due to suturing of peritoneum in TAPP.[13] On the contrary, Bittner et al., in a randomised trial of 600 patients reported higher incidence of pain in LW mesh group compared to HW mesh group in the early post-operative period.[14] This may indicate that the extent of acute inflammation in the early post-operative period is unrelated to the type of mesh used and depends more on the operative technique and extent of dissection. Recovery time is an important issue in terms of the degree of disruption to a patient's life and the cost to society calculated by days missed from productive work. In the current study, patients in LW mesh group returned to walking and driving significantly earlier than patients in HW mesh group (P value 0.002 and 0.05 respectively). However, on separate analysis in TEP and TAPP repair, we found significantly earlier return to normal activities in LW mesh group only in patients undergoing TEP repair and not in TAPP repair. Hence, the probable reason for early return to normal activities in TEP repair may be due to less pain associated with TEP as compared to TAPP repair in the early post-operative period,[13] rather than the mesh itself. These results are in accordance with the randomised trial reported by Chowbey et al., of 402 patients undergoing TEP repair in which there was significantly earlier return to normal daily activities in LW mesh group compared to HW mesh group (1.82 days vs. 2.09 days, P ≤ 0.001), while there was no significant difference in return to work in either group (7.2 vs. 7.5 days, P = 0.6). The major advantage of the LW mesh is claimed to be reduction in chronic groin pain as compared to HW mesh due to the optimal amount of MAST formation after implantation of LW meshes. Nienhuijs et al.[15] in their systematic review of 29 studies of groin hernia mesh repair reported that chronic pain had an incidence of 11%. They identified two risk factors for the development of chronic pain after inguinal hernia repair: Open surgical technique and the use of HW meshes. Bittner et al.[14] reported more pain in midweight mesh group at 6 months compared to other three groups, HW, LW and titanised mesh group. However, at 12 months follow-up they did not find any significant difference in chronic pain among the four mesh groups. Shah et al.,[16] conducted a retrospective analysis of 67 patients who undergone LIHR with either HW polypropylene mesh or LW polyester mesh and they reported a 3 times higher rate of chronic pain (18.7% vs. 5.7%, P = 0.05 in polypropylene mesh group as compared to LW mesh group at 1-year follow-up. Agarwal et al.[7] in a prospective double-blind randomised controlled study comparing LW and HW polypropylene mesh in TEP repair of inguinal hernia, showed that LW polypropylene mesh was associated with significantly better pain scores, patient comfort, and sexual functions. However, we did not find any significant difference in the incidence and severity of chronic groin pain between the HW mesh and LW mesh groups at 3 months (P = 0.9), 6 months (P = 0.4) and 12 months (P = 0.6). Most of the patients reported mild pain (VAS 1-2). Moderate to severe chronic groin pain (VAS ≥3) was seen only in 3.9% of patients, with no difference between the two groups. We also compared both the meshes in TEP and TAPP repair separately and we did not find any significant difference in the incidence or severity of chronic groin pain between the two mesh groups. In our study, the mesh was not fixed and hence pain caused by nerve damage or tissue compression produced by fixation devices can be excluded completely as a confounding factor. Chowbey et al.[8] reported that the short-term advantage of LW mesh with regards to chronic pain was lost after 3 months. Khan et al.[17] also found no difference between LW and HW mesh group at 4 and 15 months follow-up in a retrospective study conducted by telephonic conversation of 250 patients. In our study, we did not find any correlation between incidence of pain with age, occupation of the patient or with various co-morbidities like constipation, smoking, and lower urinary tracts symptoms. However, pre-operative pain, duration of symptoms and post-operative pain at 6 weeks had a significant correlation with the incidence of chronic groin pain on multivariate analysis. In contrast, a large randomised study[18] of 994 patients found no significant relation between the development of chronic groin pain and pre-operative pain (P = 0.2). The MRC study[19] found that 30% of patients reported no change in pain from before to after surgery, but that 5% felt worse than before the herniorrhaphy. The incidence of foreign body sensation after 3 months in our study was 18.3%, 15.4% in LW mesh group versus 21.2% in HW mesh group, but the difference was not statistically significant (P = 0.38). This is in accordance with the randomised trial by Bittner et al.[14] in which there was no significant difference in this parameter between LW and HW mesh groups. While, Chui et al.[12] reported significantly less foreign body sensation at 3, 6 and 12 months with LW mesh. The incidence after 3 months was 8% in LW mesh group as compared to 24% in HW mesh group (P = 0.05). Lightweight meshes are thought to be associated with higher rate of hernia recurrence as compared with HW mesh.[9] However, some studies have shown that there was no difference in recurrence rate between the two groups of meshes.[7] These studies had small cohorts and shorter follow-up. Chowbey et al.[8] reported higher recurrence rate with Ultrapro mesh (1.3%) as compared with the Prolene mesh (0.2%) (P = 0.07). Although it failed to reach the statistical significance, the difference in percentage of recurrence with LW mesh was over 6 times higher compared to HW mesh. They also reported that all five recurrences in the LW mesh group were in those with large defects. Akolekar et al.[9] reported recurrence rate of 4.3% (16/371 patients) with LW mesh and 2.82% (12/425) recurrences with HW mesh after TEP hernia repairs during median follow-up of 14.5 months and 22.5 months respectively. The difference was not significant (P = 0.2). They reported that recurrence depends on adhesions between the mesh and abdominal wall, which prevents retraction of the mesh into the abdominal wall defect. As the hernia defect increases in diameter, the adhesions strength between mesh and abdominal wall is insufficient to prevent displacement of mesh into the defect. Using a larger LW mesh or properly fixing the mesh could prevent this. There was no significant difference in recurrence rates between the LW and HW mesh group in studies by Chui et al.,[12] Agarwal et al.,[7] Bittner et al.[14] and Langenbach et al.[20] In the present study, there was one recurrence at mean follow-up of 10.1 ± 3.7 months, which was in the LW mesh group. On reoperation, the mesh was found to have migrated into the dilated internal inguinal ring and was forming part of the sac. This may be related to the soft texture and resultant displacement of mesh. We also did not fix the mesh, and since it was a large direct defect, it may have contributed to the recurrence. A measure of QOL is being used increasingly to evaluate the outcome of surgical care. Patients after inguinal hernia surgery want to return to work at the earliest in an accepted state of health. Many of the analyses of laparoscopic versus open hernia repair focused on outcome in terms of recurrence and pain. There are very few studies, which had included QOL outcomes as study end points. Post et al.[10] and Peeters et al.[21] showed significantly improved QOL after both LW and HW mesh repair following Lichtenstein and laparoscopic repair respectively. However, there was no difference in QOL scores at any study point. Similarly, in a randomised trial of LW versus HW mesh in open Lichtenstein repair by Nikkolo et al.,[22] there was no detectable difference in any dimension of QOL according to the SF 36 between the two treatment groups. However, after 6 months, there occurred a considerable improvement in the QOL in both study groups, which indicates the importance of elective hernia repair. In our study, there was significantly earlier return to walking and return to driving vehicles in LW mesh group compared to HW mesh group; however, both the groups showed significant improvement in QOL from the pre-operative period to 3 months post-operatively in 6 of the 8 domains and there was no significant difference in post-operative SF-36 scores in any of the domains between the two mesh groups. The major strength of this study is that it is a randomised clinical trial with an adequate sample size, with low dropout rates. However, the limitation in our study is that the patients underwent both TEP and TAPP repair which could alter the pain scores, and the follow-up duration is relatively small. TAPP in few studies has been shown to have a higher incidence of early post-operative pain but the incidence of chronic groin pain is reported to be similar in both the techniques,[23] which should not influence our results since the primary endpoint in our study was chronic groin pain. We have performed a per protocol analysis rather than an intention to treat analysis, because we had to exclude patients on whom we did not have data on chronic groin pain which was our primary endpoint and three patients in whom operating surgeon felt the need to use tacker because tacker in itself is one of the major reasons for higher chronic groin pain. Since the number of these patients is very small, we feel that it may not influence the overall result so much.

CONCLUSION

Laparoscopic repair of inguinal hernia using HW and LW mesh are comparable in terms of both short-term and long-term outcomes. The two procedures are equally effective in terms of acute and chronic groin pain, QOL, recurrence rates, QOL and resumption to work with LW mesh having the advantage of earlier return to walking and returning to driving vehicles. Chronic groin pain had a significant correlation with duration of symptoms, pre-operative pain and post-operative pain at 6 weeks. Though the operative time was slightly higher in LW mesh group, there was no significant difference. The overall cost was significantly less in LW mesh group. However, flat plain polypropylene mesh can be used to keep the cost of HW mesh low.
  23 in total

Review 1.  The lightweight and large porous mesh concept for hernia repair.

Authors:  Bernd Klosterhalfen; Karsten Junge; Uwe Klinge
Journal:  Expert Rev Med Devices       Date:  2005-01       Impact factor: 3.166

2.  Can we be sure polypropylene mesh causes infertility?

Authors:  Robert J Fitzgibbons
Journal:  Ann Surg       Date:  2005-04       Impact factor: 12.969

3.  Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial.

Authors:  Robert J Fitzgibbons; Anita Giobbie-Hurder; James O Gibbs; Dorothy D Dunlop; Domenic J Reda; Martin McCarthy; Leigh A Neumayer; Jeffrey S T Barkun; James L Hoehn; Joseph T Murphy; George A Sarosi; William C Syme; Jon S Thompson; Jia Wang; Olga Jonasson
Journal:  JAMA       Date:  2006-01-18       Impact factor: 56.272

4.  Laparoscopic versus open repair of groin hernia: a randomised comparison. The MRC Laparoscopic Groin Hernia Trial Group.

Authors: 
Journal:  Lancet       Date:  1999-07-17       Impact factor: 79.321

5.  Prospective, randomized, controlled trial comparing lightweight versus heavyweight mesh in chronic pain incidence after TEP repair of bilateral inguinal hernia.

Authors:  L B Chui; W T Ng; Y S Sze; K S Yuen; Y T Wong; C K Kong
Journal:  Surg Endosc       Date:  2010-04-08       Impact factor: 4.584

6.  Comparison of recurrence with lightweight composite polypropylene mesh and heavyweight mesh in laparoscopic totally extraperitoneal inguinal hernia repair: an audit of 1,232 repairs.

Authors:  D Akolekar; S Kumar; L R Khan; A C de Beaux; S J Nixon
Journal:  Hernia       Date:  2007-09-13       Impact factor: 4.739

7.  Recurrences after conventional anterior and laparoscopic inguinal hernia repair: a randomized comparison.

Authors:  Mike S L Liem; Eino B van Duyn; Yolanda van der Graaf; Theo J M V van Vroonhoven
Journal:  Ann Surg       Date:  2003-01       Impact factor: 12.969

8.  Lightweight mesh improves functional outcome in laparoscopic totally extra-peritoneal inguinal hernia repair.

Authors:  L R Khan; S Liong; A C de Beaux; S Kumar; S J Nixon
Journal:  Hernia       Date:  2009-09-11       Impact factor: 4.739

9.  Randomized clinical trial of lightweight composite mesh for Lichtenstein inguinal hernia repair.

Authors:  S Post; B Weiss; M Willer; T Neufang; D Lorenz
Journal:  Br J Surg       Date:  2004-01       Impact factor: 6.939

10.  Sixty-month follow-up after endoscopic inguinal hernia repair with three types of mesh: a prospective randomized trial.

Authors:  Mike Ralf Langenbach; Johannes Schmidt; Burkhard Ubrig; Hubert Zirngibl
Journal:  Surg Endosc       Date:  2008-04-09       Impact factor: 4.584

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  2 in total

1.  Lightweight mesh versus heavyweight mesh for laparo-endoscopic inguinal hernia repair: a systematic review and meta-analysis.

Authors:  F Wu; X Zhang; Y Liu; D Cao; Y Yu; Y Ma
Journal:  Hernia       Date:  2019-07-31       Impact factor: 4.739

2.  Randomized trial comparing self gripping semi re-absorbable mesh (PROGRIP) with polypropylene mesh in open inguinal hernioplasty: the 6 years result.

Authors:  J K M Fan; J Yip; D C C Foo; O S H Lo; W L Law
Journal:  Hernia       Date:  2016-11-26       Impact factor: 4.739

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