Preloop trial: study protocol for a randomized controlled trial

• Main Authors: Elisa Mäkäräinen-Uhlbäck, Heikki Wiik, Jyrki Kössi, Pasi Ohtonen, Tero Rautio
• Format: Article
• Language: English
• Published: BMC 2018-11-01
• Series: Trials
• Subjects: Loop-ileostomy closure; Rectal cancer; Hernia prevention; Synthetic mesh; Biological implant
• Online Access: http://link.springer.com/article/10.1186/s13063-018-2977-9

Abstract Background A temporary loop ileostomy, which is used to decrease the risk of symptomatic anastamotic leakage after anterior resection and total mesorectal excision (TME), is traditionally closed without any mesh. However, as 44% of incisional site hernias need further repair after stoma closure, attention has increasingly been paid to the use of mesh. Research on the prevention of these hernias is scarce, and no studies comparing different meshes exist. Method/Design The Preloop trial (Clinical Trials NCT03445936) is a prospective, randomized, controlled, multicenter trial to compare synthetic mesh (Parietene Macro™, Medtronic, Minneapolis, MN, USA) and biological implants (Permacol™, Medtronic) at a retromuscular sublay position for the prevention of incisional site hernias after loop-ileostomy closure. The main endpoints in this trial are infections at 30-day follow-up and the incidence of hernias clinically or on CT scan at 10 months after closure of the stoma. The secondary endpoints are other complications within 30 days of surgery graded with the Clavien-Dindo classification, reoperation rate, operating time, length of stay, quality of life measured with RAND-36, and incidence of hernia over a 5-year follow-up period. A total of 100 patients will be randomized in a 1:1 ratio. Discussion This is a pilot trial that will be undertaken to provide some novel evidence on the safety profile and efficiency of both synthetic mesh and biological implants for the prevention of incisional hernias after closure by temporary loop ileostomy. The hypothesis is that synthetic mesh is economical but equally safe and at least as effective as biological implants in hernia prevention and in contaminated surgical sites. Trial Registration ClinicalTrials.gov, NCT03445936. Registered on 7 February 2018.