INTRODUCTION: The success of laparoscopic surgery is due to the less surgical trauma, including less operative pain, complications and better cosmetics. Objective of our study was to compare in two blind randomized groups of patients, the surgical outcome of total extra-peritoneal (TEP) inguinal hernia repair using either single-port or conventional surgical technique. We will report our interim results in the first group of 50 patients. MATERIALS AND METHODS: Our study is a prospective, randomized, controlled clinical trial conducted from August 2011 to June 2013. Fifty patients aged between 21 and 80 years undergoing surgery for unilateral inguinal hernia were randomised into two groups: conventional laparoscopic TEP inguinal hernia repair versus single-port TEP repair. Clinical data on patient demographics, surgical technique and findings, postoperative complications and pain scores were collected. Primary endpoint is the postoperative pain while secondary endpoints are recurrence, chronic pain, postoperative hospital stay and complications. RESULTS: Out of the 50 patients, 26 underwent single-port hernia TEP repair and 24 had conventional 3-port TEP hernia repair after randomization. Mean operative time was 51.7 (±13.4) min in the multiport group and 59.3 (±14.9) min in the single-port group, respectively (P = 0.064). Mean hospital stay was 19.7 (±4.8) h in the conventional group and 22.1 (±4.5) h in the single-port group (P = 0.079). No statistically significant differences were observed between the two groups for postoperative complications, and no recurrence reported at 11 months follow-up. There was no significant difference in the pain scores (visual analog scale) between the two groups at regular intervals post surgery. DISCUSSION: The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are comparable to the standard three-port technique.
RCT Entities:
INTRODUCTION: The success of laparoscopic surgery is due to the less surgical trauma, including less operative pain, complications and better cosmetics. Objective of our study was to compare in two blind randomized groups of patients, the surgical outcome of total extra-peritoneal (TEP) inguinal hernia repair using either single-port or conventional surgical technique. We will report our interim results in the first group of 50 patients. MATERIALS AND METHODS: Our study is a prospective, randomized, controlled clinical trial conducted from August 2011 to June 2013. Fifty patients aged between 21 and 80 years undergoing surgery for unilateral inguinal hernia were randomised into two groups: conventional laparoscopic TEP inguinal hernia repair versus single-port TEP repair. Clinical data on patient demographics, surgical technique and findings, postoperative complications and pain scores were collected. Primary endpoint is the postoperative pain while secondary endpoints are recurrence, chronic pain, postoperative hospital stay and complications. RESULTS: Out of the 50 patients, 26 underwent single-port hernia TEP repair and 24 had conventional 3-port TEP hernia repair after randomization. Mean operative time was 51.7 (±13.4) min in the multiport group and 59.3 (±14.9) min in the single-port group, respectively (P = 0.064). Mean hospital stay was 19.7 (±4.8) h in the conventional group and 22.1 (±4.5) h in the single-port group (P = 0.079). No statistically significant differences were observed between the two groups for postoperative complications, and no recurrence reported at 11 months follow-up. There was no significant difference in the pain scores (visual analog scale) between the two groups at regular intervals post surgery. DISCUSSION: The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are comparable to the standard three-port technique.
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