Preloop trial: study protocol for a randomized controlled trial.

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

SUBMITTER: Makarainen-Uhlback E 

PROVIDER: S-EPMC6230220 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature