PREEMER trial: Study protocol for a randomized controlled trial

Abstract

Background: Despite the fact that, in itself, emergency midline laparotomy is a factor risk for an incisional hernia, active research on hernia prevention in emergency settings is lacking. Different kinds of meshes and mesh positions have been studied in elective abdominal surgery, but no randomized controlled trials in emergency settings have been published.Methods: The PREEMER trial is a multicenter, double-blinded, randomized controlled trial to be conducted in seven hospitals in Finland (Oulu, Helsinki, Tampere, and Turku university hospitals and Jyväskylä, Lahti, and Seinäjoki non-university hospitals). A total of 244 patients will be randomized at a 1:1 ratio to either the retrorectus mesh group, featuring a self-gripping prophylactic mesh, or to the no mesh (control) group, both closed by small stitch 4:1 closure with continuous slowly absorbable monofilament suturing. The primary outcome of the PREEMER trial is the incisional hernia incidence two years after surgery, which will be detected clinically and/or radiologically. Secondary outcomes are the Comprehensive Complication Index score, incidence of surgical site infections and fascial dehiscence within 30 days of surgery; the incisional hernia repair rate and mesh- or hernia-related re-operations within the two- and five-year follow-ups; the incidence of incisional hernia within the five-year follow-up; and quality of life measured by RAND-36, the Activities Assessment Scale (AAS), and the PROMIS-questionnaire within 30 days and two and five years from surgery. Additionally, medico-economic explorative measures are analyzed.Discussion: The PREEMER Trial will provide level 1 evidence on incisional hernia prevention in an emergency setting.Trial registration: Clinical Trials NCT04311788https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009MXF&selectaction=Edit&uid=U0003YIA&ts=2&cx=7ef75k. Registered March 7th, 2020