Sujith Wijerathne1,2, Narendra Agarwal3, Ahmad Ramzi3, Dino H Liem3, Wee B Tan3, Davide Lomanto3. 1. Department of Surgery, Minimally Invasive Surgical Centre, National University Health System, Singapore, Singapore. sujithwijerathne@gmail.com. 2. Department of General Surgery, National University Health System, NUHS Tower Block, Level 08, 1E, Kent Ridge Road, Singapore, 119228, Singapore. sujithwijerathne@gmail.com. 3. Department of Surgery, Minimally Invasive Surgical Centre, National University Health System, Singapore, Singapore.
Abstract
BACKGROUND: The advantage of single-port total extra-peritoneal (TEP) inguinal hernia repair over the conventional technique is still debatable. Our objective was to compare the outcomes of TEP inguinal hernia repair using either a single-port or conventional surgical technique, in two blind randomized groups of patients. METHODS: In this prospective, randomized, double-blind, controlled clinical trial, 100 patients undergoing surgery for unilateral inguinal hernia were randomized into two groups: One group underwent conventional laparoscopic TEP inguinal hernia repair, while the other was selected for single-port TEP repair. Primary endpoint is postoperative pain (VAS), while secondary endpoints are recurrence, chronic pain and complications. RESULTS:From 100 patients, 49 underwentsingle-port hernia TEP repair, 50 had conventional three-port TEP hernia repair, and one patient declined to participate after randomization. The two groups were comparable in terms of patient demographics and operative findings. Mean operative time was 49.1(±13.8) min in the conventional group and 54.1(±14.4) min in the single-port group (p = 0.08). Mean hospital stay was 19.7(±5.8) h in the conventional group and 20.5(±6.4) h in the single-port group (p = 0.489). No major complications and no recurrence reported at 11-month follow-up. No statistically significant difference noted in postoperative pain between the two groups at regular intervals. CONCLUSIONS: The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are similar but not superior to the conventional technique.
RCT Entities:
BACKGROUND: The advantage of single-port total extra-peritoneal (TEP) inguinal hernia repair over the conventional technique is still debatable. Our objective was to compare the outcomes of TEPinguinal hernia repair using either a single-port or conventional surgical technique, in two blind randomized groups of patients. METHODS: In this prospective, randomized, double-blind, controlled clinical trial, 100 patients undergoing surgery for unilateral inguinal hernia were randomized into two groups: One group underwent conventional laparoscopic TEPinguinal hernia repair, while the other was selected for single-port TEP repair. Primary endpoint is postoperative pain (VAS), while secondary endpoints are recurrence, chronic pain and complications. RESULTS: From 100 patients, 49 underwent single-port herniaTEP repair, 50 had conventional three-port TEPhernia repair, and one patient declined to participate after randomization. The two groups were comparable in terms of patient demographics and operative findings. Mean operative time was 49.1(±13.8) min in the conventional group and 54.1(±14.4) min in the single-port group (p = 0.08). Mean hospital stay was 19.7(±5.8) h in the conventional group and 20.5(±6.4) h in the single-port group (p = 0.489). No major complications and no recurrence reported at 11-month follow-up. No statistically significant difference noted in postoperative pain between the two groups at regular intervals. CONCLUSIONS: The outcomes after laparoscopic TEPinguinal hernia repair with a single-port device are similar but not superior to the conventional technique.
Entities:
Keywords:
Inguinal hernia; Randomized trial; Single port; Total extra-peritoneal (TEP)
Authors: M Miserez; J H Alexandre; G Campanelli; F Corcione; D Cuccurullo; M Hidalgo Pascual; A Hoeferlin; A N Kingsnorth; V Mandala; J P Palot; V Schumpelick; R K J Simmermacher; R Stoppa; J B Flament Journal: Hernia Date: 2007-03-13 Impact factor: 4.739