Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial

Background The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5–30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely. Methods The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants’ health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed. Discussion This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia. Trial registration ClinicalTrials.govNCT03623893. Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018

Contralateral exploration and repair of occult inguinal hernias during laparoscopic inguinal hernia repair: systematic review and Markov decision process

Background Contralateral clinically occult hernias are frequently noted at the time of laparoscopic unilateral inguinal hernia repair. There is no consensus on the role of contralateral exploration and repair. This systematic review assessed the safety and efficacy of operative repair of occult contralateral inguinal hernias found during unilateral repair. Methods PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched from inception to February 2020. Adults diagnosed with a unilateral inguinal hernia undergoing laparoscopic repair were included. The primary outcome was the incidence of occult contralateral hernias. Summative outcomes of operative and expectant management were reported along with development of a Markov decision process. Results Thirteen studies (1 randomized trial, 12 observational cohorts) with 5000 patients were included. The incidence of occult contralateral inguinal hernias was 14.6 (range 7.3–50.1) per cent. Among patients who underwent repair, 10.5 (4.3–17.0) per cent experienced a postoperative complication. Of patients managed expectantly, 29 per cent later required elective repair for symptoms. Mean follow-up was 36 (range 2–218) months. Using a Markov decision process, it was calculated that, for every 1000 patients undergoing unilateral inguinal hernia repair, contralateral exploration would identify 150 patients with an occult hernia. Repair would result in 15 patients developing a postoperative complication and 105 undergoing unnecessary repair. Alternatively, expectant management would result in 45 patients requiring subsequent repair. Conclusion Contralateral repair is not warranted in patients with occult hernias diagnosed at the time of elective hernia repair. The evidence is largely based on observational studies at high risk of bias.