Randomized clinical trial of intracutaneously versus transcutaneously sutured ileostomy to prevent stoma-related complications (ISI trial)

BackgroundIleostomy construction is a common procedure but can be associated with morbidity. The stoma is commonly secured to the skin using transcutaneous sutures. It is hypothesized that intracutaneous sutures result in a tighter adherence of the peristomal skin to the stoma plate to prevent faecal leakage. The study aimed to compare the effect of intracutaneous versus transcutaneous suturing of ileostomies on faecal leakage and quality of life. MethodsThis randomized trial was undertaken in 11 hospitals in the Netherlands. Patients scheduled to receive an ileostomy for any reason were randomized to intracutaneous or transcutaneous suturing (IC and TC groups respectively). The primary outcome was faecal leakage. Secondary outcomes were stoma-related quality of life and costs of stoma-related materials and reinterventions. ResultsBetween April 2011 and February 2016, 339 patients were randomized to the IC (170) or TC (169) group. Leakage rates were higher in the IC than in the TC group (524 versus 414percent respectively; risk difference 110 (95percent c.i. 03 to 212)percent). Skin irritation rates were high (782 versus 722percent), but did not differ significantly between the groups (risk difference 61 (95percent c.i. -32 to 1510)percent). There were no significant differences in quality of life or costs between the groups. ConclusionIntracutaneous suturing of an ileostomy is associated with more peristomal leakage than transcutaneous suturing. Overall stoma-related complications did not differ between the two techniques. Registration number: NTR2369 (http://www.trialregister.nl).