Application of one-stitch modified ileostomy in laparoscopic low anterior rectal resection: An open-label, randomized clinical trial.

Abstract

To reduce anastomotic leakage risk, protective ileostomy is commonly used. This study aims to compare the clinical advantages of one-stitch modified ileostomy and conventional ileostomy in patients with rectal cancer. This study was designed as a single-center, prospective, randomized, open-label, blinded endpoint (PROBE) trial (Registration No. ChiCTR1900025444). A total of 189 patients were enrolled: 93 cases in the conventional ileostomy group and 96 cases in the one-stitch modified ileostomy group. The primary endpoints included the incidence of peristomal dermatitis. Secondary endpoints comprised operative time, stoma reversal time, weekly stoma bag changes, and degree of stoma adhesion. The incidence of peristomal dermatitis was significantly lower in the one-stitch modified ileostomy group (6.3%) compared with the conventional ileostomy group (17.2%, P = .034), whereas no significant differences were observed in the incidence of other stoma-related complications. The one-stitch modified ileostomy group had a lower discoloration, erosion, and tissue overgrowth score than the conventional ileostomy group (P = .011). The mean operative times of resection and closure in the one-stitch modified ileostomy group were significantly shorter than those in the conventional ileostomy group (195.0 vs 217.5 minutes, 71.0 vs 88.5 minutes, P < .001). The one-stitch modified ileostomy group had fewer weekly stoma bag changes than the conventional ileostomy group (P = .039), suggesting reduced stoma care burden. In addition, the degree of stoma adhesion was significantly milder in the one-stitch modified ileostomy group compared with the conventional ileostomy group (P = .030). This study suggests that one-stitch modified ileostomy is a safe, feasible, and advantageous stoma technique.