The INTESTINE study: INtended TEmporary STomas In crohN’s diseasE. Protocol for an international multicentre study

Abstract

Surgery for ileocolonic Crohn’s disease can result in temporary or permanent stoma formation which can be associated with morbidity as parastomal and incisional hernias, readmissions due to obstruction or high stoma output, and have a negative impact on quality of life. We propose an international retrospective trainee-led study of the outcomes of temporary stomas in patients with Crohn’s disease. We aim to evaluate both the short-term (6 month) and mid-term (18 month) outcomes of temporary stomas in patients with Crohn’s Disease. Retrospective, multicentre, observational study including all patients who underwent elective or emergency surgery for ileal, colonic and ileocolonic Crohn’s disease during a 4-year study period. Primary outcome is the proportion of patients who still have an ileostomy or colostomy 18 months after the initial surgery. Secondary outcomes: complications related to stoma formation and stoma reversal surgery; time interval between stoma formation and stoma reversal; risk factors for stoma formation and non-reversal of the stoma. We present the study protocol for a trainee-led, multicentre, observational study. Previous research has demonstrated significant heterogeneity surrounding the formation and the timing of reversal surgery in patients having a temporary ileostomy following colorectal cancer surgery, highlighting the need to address these same questions in Crohn’s disease, which is the aim of our research.