Pankaj Garg, MBBS MS, Srijith Nair, MBBS MS, Geetha R Menon, PhD, Jai D Thakur, MBBS, Mohamed Ismail, MBBS MS. 1.Fortis Super Specialty Hospital,Mohali, India 2.Moulana Hospital, Perianthalmanna, Kerala, India 3. Indian Council of Medical Research, New Delhi, India 4. University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
Background– Previous studies have shown that non-fixation of mesh in TEP is safe and comparable to mesh fixation in terms of recurrence rate, pain scores and other morbidity parameters. The present study was planned in a rural hospital in south India to compare the effect of non-fixation of mesh to its fixation in laparoscopic total extraperitoneal (TEP) inguinal hernia repair.
Methods– 104 patients were randomized to mesh non-fixation or fixation group during TEP. A previous study with a large sample size was used as the reference study for calculation of the sample size¹. Individuals over 16 years of age, diagnosed with a primary, unilateral or bilateral reducible inguinal hernia were eligible to be enrolled for randomization. Obstructed and strangulated hernias, recurrent hernia, patients with associated hernias (like ventral hernia), history of previous lower abdominal surgery (Pfannenstiel incision, preperitoneal procedure etc) and patients unfit for anesthesia (American Society of Anesthesiology grade>2) were excluded from the trial. The primary outcome measure was post operative pain at one month and recurrence at one year. The secondary endpoints were seroma formation, urinary retention, resumption of normal activities, postoperative pain at one day, one week and after one year. The post operative pain scores were measured on VAS (Visual analogue scale). The trial was registered at www.clinicaltrials.gov (ID: NCT01117337) and at the national registry of clinical trials in India, www.ctri.in (CTRI/2009/091/000020).
Results– 104 patients (194 hernias) were randomized to mesh non-fixation or fixation group. The follow-up ranged from 15-19 months with a median of 16.2 months. One year follow-up was completed in 100 patients (186 hernias)- 52 patients(96 hernias) in Non-fixation group and 48 patients(90 hernias) in Fixation group. The operating time was significantly more in the fixation group (Fix-37.7±4.3 min, Non-fix – 35.9±3.6 min, p=0.022, t-test). The pain scores at 24 hours were comparable in both the groups (Fix-1.31±0.4, Non-fix- 1.42±0.5, p=0.23, t-test). The hospital stay (Fix-1.12±0.3 days, Non-fix-1.15±0.4 days, p=0.7, t-test) and days taken to resume normal activities (Fix-7.77±1.3 days, Non-fix – 7.96±1.15 days, p=0.44, t-test) were also similar in both the groups. The proportion of patients with seroma formation were comparable in both the groups (Fix-10.4% vs Non-Fix-15.4%, p=0.56, t-test). The proportion of patients having pain at one week (Fix-20.8%, Non-fix-25%, p=0.64, Fisher exact test), at one month (Fix-6.2%, Non-fix-15.3%, p=0.2, Fisher exact test), and at one year (Fix-4.0%, Non-fix-13.4%, p=0.16, Fisher exact test) were comparable in both the groups. There was no recurrence in either groups at a minimum follow-up of 15 months.
Conclusions: Compared to fixation of mesh, non-fixation during TEP had similar postoperative pain, hospital stay, resumption of normal activities, seroma formation and recurrence rate. Non-fixation of mesh is safe and recommended during TEP in experienced hands, even in rural settings.
1. Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009;23: 1241-1245
Program Number: S077