CAF-QoL-C4
Research type
Research Study
Full title
Validation of the CAF-QoL in Patients with Poor Wound Healing and Persistent Perineal Sinuses Following Proctectomy for Perianal Crohn’s Disease
IRAS ID
355493
Contact name
Phil Tozer
Contact email
Sponsor organisation
LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Crohn’s disease is a condition that makes parts of the bowel inflamed. In some people, it can affect the anus and the area around it (perianal Crohn’s disease). Some patients with this condition need surgery (proctectomy) to remove the lower bowel and anus, leaving them with a stoma bag. Around one third of these patients have ongoing wound problems after surgery, like pain, infection and leakage. There are many treatment options for these conditions, including medications, surgery and newer treatments like hyperbaric oxygen therapy. However, current research into these treatments is weak, and usually does not include an assessment of the impact of the treatments on to patient’s symptoms and wellbeing.
Assessing patient quality of life is essential in clinical trials for perianal Crohn’s disease. A tool called the Crohn’s Anal Fistula Quality of Life questionnaire (CAF-QoL) was developed to measure the impact of anal fistulas. While various quality-of-life measures exist, no specific tool is available for assessing treatment outcomes in patients with poor wound healing after proctectomy. The aim of this study is to adjust CAF-QoL and test it to ensure that is valid for use in this group of patients. This will be done by asking patients with the condition to complete and assess CAF-QoL in comparison to other questionnaires, using an online survey. This research will allow future researchers to carry out better studies to improve treatment of this group of patients.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
26/SC/0043
Date of REC Opinion
9 Apr 2026
REC opinion
Further Information Favourable Opinion