Prospective, Randomized Study on the Use of a Prosthetic Mesh for Prevention of Parastomal Hernia of Permanent Colostomy.

Vierimaa, Mika; Klintrup, Kai; Biancari, Fausto; Victorzon, Mikael; Carpelan-Holmström, Monika; Kössi, Jyrki; Kellokumpu, Ilmo; Rauvala, Erkki; Ohtonen, Pasi; Mäkelä, Jyrki; Rautio, Tero

BACKGROUND Prophylactic placement of a mesh has been suggested to prevent parastomal hernia, but evidence to support this approach is scarce. OBJECTIVE The aim of this study was to evaluate whether laparoscopic placement of a prophylactic, dual-component, intraperitoneal onlay mesh around a colostomy is safe and prevents parastomal hernia formation after laparoscopic abdominoperineal resection. DESIGN This is a prospective, multicenter, randomized controlled clinical trial. SETTINGS This study was conducted at 2 university and 3 central Finnish hospitals. PATIENTS From 2010 to 2013, 83 patients undergoing laparoscopic abdominoperineal resection for rectal cancer were recruited. After withdrawals and exclusions, the outcome of 70 patients, 35 patients in each study group, could be examined. INTERVENTIONS In the intervention group, an end colostomy was created with placement of a intraperitoneal, dual-component onlay mesh and compared with a group with a traditional stoma. MAIN OUTCOME MEASURES The main outcome measures were the incidence of clinically and radiologically detected parastomal hernias and their extent 12 months after surgery. Stoma-related morbidity and the need for surgical repair of parastomal hernia were secondary outcome measures. RESULTS Parastomal hernia was observed by clinical inspection in 5 intervention patients (14.3%) and in 12 control patients (32.3%; p = 0.049). Surgical repair of parastomal hernia was performed in 1 control patient (3.2%) and in none of the patients in the intervention group. CT detected parastomal hernia in 18 intervention patients (51.4%) and in 17 control patients (53.1%; p = 1.00). The extent of hernias was similar according to European Hernia Society classification (p = 0.41). Colostomy-related morbidity (32.3% vs 14.3%; p = 0.140) did not differ between the study groups. LIMITATIONS The study was limited by its small size and short follow-up time. CONCLUSIONS Prophylactic laparoscopic placement of intraperitoneal onlay mesh does not significantly reduce the overall risk of radiologically detected parastomal hernia after laparoscopic abdominoperineal resection. However, prophylactic mesh repair was associated with significantly lower risk of clinically detected parastomal hernia.