BACKGROUND: A loop ileostomy is generally created during restorative proctocolectomy (RPC) for treating ulcerative colitis (UC), and an ostomy rod is often used to prevent stoma retraction. However, its usefulness or harmfulness has not been proven. We performed a prospective randomized control study to investigate the non-inferiority of ostomy creation without a rod to prevent stoma retraction. METHODS: Patients with UC who underwent RPC were enrolled and randomly divided into groups either with or without ostomy rod use. Incidences of stoma retraction and dermatitis were compared. RESULTS: Of the 320 patients in the study groups, 308 qualified for the intention-to-treat (ITT) analysis, and 257 were included in the per-protocol (PP) analysis. Ostomy retraction was recognized in 6 patients, 3 with a rod and 3 without. The difference with rod use (95% confidence interval) was 0.1 (-2.9 to 3.1)% in the PP analysis and 0.0 (-2.2 to 2.2)% in the ITT analysis. There were no significant differences in stoma retraction regardless of whether an ostomy rod was used in either analysis. Dermatitis was more common in patients with rod use (84/154) than in those without (40/154) (p < 0.01). CONCLUSIONS: Although median body mass indices were extremely low (20 kg/m2), an ostomy rod is not routinely needed as it may increase the risk of dermatitis. However, results in obese patients may differ from those shown here, which should be clarified via further studies.
BACKGROUND: A loop ileostomy is generally created during restorative proctocolectomy (RPC) for treating ulcerative colitis (UC), and an ostomy rod is often used to prevent stoma retraction. However, its usefulness or harmfulness has not been proven. We performed a prospective randomized control study to investigate the non-inferiority of ostomy creation without a rod to prevent stoma retraction. METHODS:Patients with UC who underwent RPC were enrolled and randomly divided into groups either with or without ostomy rod use. Incidences of stoma retraction and dermatitis were compared. RESULTS: Of the 320 patients in the study groups, 308 qualified for the intention-to-treat (ITT) analysis, and 257 were included in the per-protocol (PP) analysis. Ostomy retraction was recognized in 6 patients, 3 with a rod and 3 without. The difference with rod use (95% confidence interval) was 0.1 (-2.9 to 3.1)% in the PP analysis and 0.0 (-2.2 to 2.2)% in the ITT analysis. There were no significant differences in stoma retraction regardless of whether an ostomy rod was used in either analysis. Dermatitis was more common in patients with rod use (84/154) than in those without (40/154) (p < 0.01). CONCLUSIONS: Although median body mass indices were extremely low (20 kg/m2), an ostomy rod is not routinely needed as it may increase the risk of dermatitis. However, results in obesepatients may differ from those shown here, which should be clarified via further studies.
Authors: F Ferrara; D Parini; A Bondurri; M Veltri; M Barbierato; F Pata; F Cattaneo; A Tafuri; C Forni; G Roveron; G Rizzo Journal: Tech Coloproctol Date: 2019-10-12 Impact factor: 3.781