Hughes Abdominal Repair Trial - abdominal wall closure technique to reduce incidence of incisional hernias: multi-centre pragmatic randomised trial

Design: Multi-centre pragmatic randomized controlled trial. Setting: Hospital inpatients, colorectal cancer outpatient clinics. Strategy for reviewing literature: We have searched multiple databases including Cochrane, OVID and PubMed for the terms "incisional hernia”, "laparotomy", "closure" and their synonyms. We also searched the references of relevant articles and abstracts. This search yielded 14,710 titles, of which 291 were selected for abstract review and 98 publications for full review. 66 were judged as relevant to the trial. We have performed a systematic review of the available evidence of incisional hernias (IHs) after laparotomy wounds, assessing: rates of IHs detected during clinical examination (+/-radiological imaging) at one year post op and further follow up, rates of symptomatic IHs, rates of emergency repairs required for IHs, effect(s) of IHs on Quality of Life (QoL) and other key outcome measures. Target population: All patients undergoing surgery for colorectal cancer involving a midline incision. Due to the pragmatic design of the study, it will include elective and emergency patients undergoing open or laparoscopic assisted surgery with a midline specimen extraction site. Randomisation will be stratified to these variables, and to consultant surgeon. Health technology to be assessed: The ‘Hughes Repair’ [1] is a method of abdominal wall closure first described by the emeritus Professor of Surgery at the University of Wales, School of Medicine. In addition to the frequently utilised continuous ‘mass closure’ suture method described by Jenkins [2], the Hughes Repair involves a horizontal and two vertical mattress sutures within a single suture, thus closing the fascia using a series of interrupted sutures. This double mattress suture technique theoretically distributes the load along the incision length as well as across it. It is described for closure of patients at high risk of IH or following a ‘burst abdomen’, and is also used as an alternative to the standard mesh repair in treating patients with IHs [1, 3, 4]. Measurement of cost and outcome: The primary outcome measure will be the rates of IHs one year post operatively. This is a well recognised primary outcome from allied studies examining interventions designed to alter rates of IHs [5, 6]. One year follow up allows a time interval for IHs to develop and become clinically identifiable (>50% will be evident by this time [7]) and avoids increased loss-to-follow up with a longer primary outcome. The definition used herein for an IH is as per the 2009 consensus opinion of the European Hernia Society: “Any abdominal wall gap with or without a bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging’’ [8]. Our definition thus includes both clinically and radiologically detected hernias, as used by others in similar trials [5, 9, 10]. Radiological detection is used to identify those hernias which may be missed on clinical examination due to their small size, and/or patient obesity [9, 11], pain limiting adequate examination and scarring [12]. We felt that inclusion of this subset of patients (approximately 20% of all identified IHs [9]) is essential – those found to have hernias on imaging alone essentially have occult hernias, but are still at risk of complications such as strangulation and pain. We also hypothesise that a certain proportion of those diagnosed with IHs on CT alone will progress to clinical hernias at longer follow up. Though the Core Outcome Measures in Effectiveness Trials (COMET) initiative plan to identify key outcomes for IHs, none are currently available (www.comet-initiative.org). Secondary outcomes will include: QoL, cost, incidence of post operative ‘burst abdomen’ (full thickness abdominal wall dehiscence). Recognising that including a radiological diagnosis of IH in our primary outcome is open to debate, we shall undertake two secondary analyses; 1st a sensitiv