Intracutaneously versus transcutaneously sutured ileostomy: a randomized multicenter trial (ISI trial)

INTERVENTION: The objective of this trial is to compare the effectiveness of intracutaneously versus transcutaneously sutured ileostomy to reduce leakage, costs and to improve patients’quality of life. The transcutaneous character of the stitches can cause skin irritation around the stitches, it might cause leakage of feces under the stoma plaque thereby increasing skin irritation and early release of stoma plaque. This will also increase costs, because the stoma materials will have to be changed more often. The trial is designed as a 10‐center randomized clinical trial including all patients who receive an ileostomy. Patients will be randomized to receive either an intracutaneously or transcutaneously sutured ileostomy. CONDITION: Attachment, Ileostomy, Leakage, Feces, Skin irritation ; ; PRIMARY OUTCOME: Leakage of feces under the stoma plaque and peristomal dermatitis around the stitches or due to leakage of feces. SECONDARY OUTCOME: 1. Quality of life, as measured by the Stoma‐Qol; ; ; 2. Stoma‐related morbidity; ; ; 3. Cost analysis (Stoma materials and outpatient visits). ; INCLUSION CRITERIA: 1. All patients who receive an end or loop ileostomy; 2. Age between 18 and 80 years; 3. Written informed consent.