Identifying Outcomes in Clinical Trials of Fistulizing Crohn's Disease for the Development of a Core Outcome Set

Christopher Ma; Claire E Parker; Tran M Nguyen; Reena Khanna; Brian G Feagan; Vipul Jairath

doi:10.1016/j.cgh.2018.10.004

Identifying Outcomes in Clinical Trials of Fistulizing Crohn's Disease for the Development of a Core Outcome Set

Clin Gastroenterol Hepatol. 2019 Aug;17(9):1904-1908. doi: 10.1016/j.cgh.2018.10.004. Epub 2018 Oct 4.

Authors

Christopher Ma¹, Claire E Parker², Tran M Nguyen², Reena Khanna³, Brian G Feagan⁴, Vipul Jairath⁵

Affiliations

¹ Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada; Robarts Clinical Trials, Inc, London, Ontario, Canada.
² Robarts Clinical Trials, Inc, London, Ontario, Canada.
³ Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada.
⁴ Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
⁵ Robarts Clinical Trials, Inc, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada. Electronic address: vjairath@uwo.ca.

PMID: 30292887
DOI: 10.1016/j.cgh.2018.10.004

Abstract

Fistulizing complications develop in approximately one third of patients with Crohn's disease (CD), resulting in morbidity and impaired quality of life.¹ Sites of fistulae most commonly include perianal fistulae, but also enterocutaneous, enteroenteric, enterovesical, and rectovaginal. Its management requires combined medical and surgical strategies to prevent abscess formation and induce healing. Biologic agents have improved the medical treatment of CD-related fistulae, but many patients still require surgical intervention. Hence, there is considerable interest in the development of novel pharmaceutical agents to treat fistulizing CD.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Crohn Disease / physiopathology
Crohn Disease / therapy*
Cutaneous Fistula / physiopathology
Cutaneous Fistula / therapy*
Female
Gastrointestinal Agents / therapeutic use
Humans
Immunosuppressive Agents / therapeutic use*
Intestinal Fistula / physiopathology
Intestinal Fistula / therapy*
Male
Mesenchymal Stem Cell Transplantation*
Outcome Assessment, Health Care
Quality of Life
Randomized Controlled Trials as Topic
Rectal Fistula / physiopathology
Rectal Fistula / therapy
Rectovaginal Fistula / physiopathology
Rectovaginal Fistula / therapy
Treatment Outcome
Tumor Necrosis Factor Inhibitors / therapeutic use*
Urinary Fistula / physiopathology
Urinary Fistula / therapy*

Substances

Gastrointestinal Agents
Immunosuppressive Agents
Tumor Necrosis Factor Inhibitors

Grants and funding

CIHR/Canada