Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.

Talat Bessissow, Neeraj Narula, Sudheer K Vuyyuru, Florian Rieder, Tran M Nguyen, Christopher Ma, Vipul Jairath, Tanmay Sharma, Siddharth Singh

Journal: Inflammatory bowel diseases 2024;30(11):2037-2045

PMID: 38135729

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Abstract

BACKGROUND

This systematic review was performed to characterize the landscape of research conducted in patients with intestinal stoma (IS) and highlight unmet needs for clinical research in Crohn's disease (CD) and IS.

METHODS

We searched ClinicalTrials.gov from inception to May 25, 2022, to identify clinical trials assessing interventions in patients with an IS, as well as those with an IS and CD. Studies were grouped according to type of intervention. We excluded observational studies with no treatment arm.

RESULTS

A total of 253 studies were included in the final analysis. Most studies investigated devices (n = 122 [48.2%]), or surgical procedures (n = 63 [24.9%]), followed by behavioral interventions (n = 30 [11.8%]), drugs (n = 20 [7.9%]), dietary interventions (n = 2 [0.8%]), skin care products (n = 2 0.8%]), and others (n = 14 [5.5%]). A total of 50.9% (n = 129) of studies had completed recruitment, enrolling 11 116 participants. Only 6 studies (surgery: n = 3; physiological studies: n = 2; drugs: n = 1) exclusively included patients with inflammatory bowel disease (IBD), and 16 studies commented that patients with IBD were excluded in their eligibility criteria. No study assessed efficacy of drugs in patients with CD and IS. Approximately one-quarter of studies (n = 65 of 253) included quality of life as an outcome measure.

CONCLUSION

There is a paucity of research in IBD patients with IS, with the majority focusing on devices and surgical procedures. There have been no drug trials evaluating efficacy in patients with CD and IS. There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures that enable the inclusion of patients with CD with stoma into clinical trials.

© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact [email protected].

Address: Division of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, ON, Canada.; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.; Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, AB, Canada.; Lawson Health Research Institute, Western University, London, ON, Canada.; Division of Gastroenterology, Department of Medicine, McGill University Health Center, Montreal, QC, Canada.; Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada.; Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, CA, USA.; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.; Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.; Division of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, ON, Canada.; Lawson Health Research Institute, Western University, London, ON, Canada.; Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.

DOI: 10.1093/ibd/izad293

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MeSH Terms: Humans, Inflammatory Bowel Diseases, Clinical Trials as Topic, Surgical Stomas, Crohn Disease, Quality of Life, Registries