Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583] (Trials)

Background: The optimal strategy for abdominal wall closure has been an issue of ongoing debate.Available studies do not specifically enroll patients who undergo emergency laparotomy andthus do not consider the distinct biological characteristics of these patients. The presentrandomized controlled trial evaluates the efficacy and safety of two commonly appliedabdominal wall closure strategies in patients undergoing primary emergency midlinelaparotomy. Methods: The CONTINT trial is a multicenter, open label, randomized controlled trial with a twogroupparallel design. Patients undergoing a primary emergency midline laparotomy areenrolled in the trial. The two most commonly applied strategies of abdominal wall closureafter midline laparotomy are compared: the continuous, all-layer suture technique usingslowly absorbable monofilament material (two Monoplus(R) loops) and the interrupted suturetechnique using rapidly absorbable braided material (Vicryl(R) sutures). The primary endpointwithin the CONTINT trial is an incisional hernia within 12 months or a burst abdomen within30 days after surgery. As reliable data on this primary endpoint is not available for patientsundergoing emergency surgery, an adaptive interim analysis will be conducted after theinclusion of 80 patients, allowing early termination of the trial if necessary or modification ofdesign characteristics such as recalculation of sample size.DiscussionThis is a randomized controlled multicenter trial with a two-group parallel design to assessthe efficacy and safety of two commonly applied abdominal wall closure strategies in patientsundergoing primary emergency midline laparotomy.Trial registrationNCT00544583