Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial

摘要

A quality metric for centers performing rectal cancer surgery is a high percentage of sphincter sparing procedures. These procedures often involve temporary bowel diversion to minimize the complications of an anastomotic leak. The most common strategy is a diverting loop ileostomy which is then closed after completion of adjuvant therapy or the patient recovers from surgery. Loop ileostomy is not without complications and the closure is complicated by a one in three chance of incisional hernia development. Strategies to prevent this problem have been designed using a variety of techniques with and without mesh placement. This proposed pilot study will test the safety and efficacy of a novel stoma closure technique involving permanent mesh in the retro rectus position during ileostomy closure. The study will prospectively follow 20 patients undergoing ileostomy closure using this technique and evaluate for safety of the procedure, quality of life, and feasibility for a larger randomized controlled trial. Patients will be followed post procedurally and evaluated for 30-day complications, as well as followed up with routine cancer surveillance computed tomography every 6 months in which the presence of stoma site incisional hernias will be evaluated. The results of this pilot study will inform the design of a multiple center, blinded randomized controlled trial to evaluate the utility of permanent mesh placement to decrease the incidence of prior stoma site incisional hernias.