A Prospective Randomized Controlled Trial to Compare Single-port Endo-laparoscopic Surgery vs Conventional Tep Inguinal Hernia Repair

Sujith I Wijerathne, MBBS, MRCS, Narendra Agarwal, MBBS, MS, Ahmad Ramzi, MD, Davide Lomanto, MD, PhD, FAMS. Minimally Invasive Surgical Centre, Department of Surgery; National University Health System, Singapore.

The success of laparoscopic surgery was due to the less surgical trauma, including less operative pain, complications and better cosmetics. Evolution in the last decades has brought new advancement to further reduce trauma and improve patient’s outcome and among them the single access or reduced port surgery. Several studies and reports describe feasibility and safety in different surgical procedures but very few RCTS are published. Objective of our study is 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

Our study is a prospective, randomised, controlled clinical trial conducted from August 2011 to June 2013 in our institution with DSRB approval (2011/00092). 50 patients aged between 21-80 years undergoing surgery for unilateral inguinal hernia were randomised into 2 groups: one group underwent conventional laparoscopic TEP inguinal hernia repair while the other group was selected for single port TEP Repair. Patients with bleeding disorders, incarcerated, recurrent or bilateral hernia and previous lower abdominal surgery were excluded. Clinical Data on patient demographics, surgical technique and findings, post-operative complications were collected; pain scores using Visual Analogue Scale (VAS) were collected blindly post-operatively and standard analgesia administered. All data were analysed using SPSS software. Primary endpoint is the VAS while secondary end-points are recurrence, chronic pain and complications.

Out of the 50 patients, 26 underwent single port hernia TEP repair and 24 had conventional 3-port TEP hernia repair after randomisation. The two groups were comparable in terms of co-morbidities, patient demographics, mesh type and operative findings and no statistically significant differences were observed. Mean operative time was 51.7±13.4 min. in the multiport group and 59.3 ±14.9) minutes in the single-port group respectively (p=0.064). Mean hospital stay was 19.7±4.8 hours in the conventional group and 22.1±4.5 hours in the single port group (p=0.079). No statistically significant differences were observed between the two groups for post-operative complications and no recurrence reported at 11 months follow-up. Mean VAS at 6 hours post-surgery was 2.7±1.7 in the conventional group and 2±1.8 in the single-port group (p=0.187). VAS was 0 in both groups at 6 months. Size scar in the single port group was 13 mm

The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are similar to the standard three-port technique, adding the obvious effect on better cosmesis.

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