Developing a pouch anal and vaginal fistula core outcome Set -V1
Research type
Research Study
Full title
The development of a Core Outcome Set for Pouch Anal and Vaginal Fistula (PAVF-COS) using a Delphi study
IRAS ID
280365
Contact name
Philip Tozer
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
Restorative proctocolectomy is used to restore gastrointestinal continuity following removal of the large bowel and rectum for ulcerative colitis or familial adenomatous polyposis syndrome. This involves using a segment of small bowel to create a reservoir which performs a similar function to the rectum. The ileum is sutured or stapled to the top of the anus. The anal sphincter maintains continence. This is called an ileoanal pouch. The main aim of the pouch is to avoid a permanent stoma, improving patient quality of life.\n\nAn abnormal tunnel may develop between the ileoanal pouch and the surrounding structures in 4.5% of patients. This is called a fistula. The most common types of fistula are pouch anal and pouch vaginal fistula. These can cause significant discharge and pain. In 30% of patients, the fistula fails to heal despite various treatments, eventually requiring removal of the pouch and a permanent stoma. Clinical studies have been conducted to assess the effectiveness of different treatment modalities in these fistulae. However, these studies do not assess the same outcomes following treatment. This makes it difficult for clinicians to compare outcomes between studies. \n\nA Core Outcome Set would be useful for interventional studies in pouch-anal and pouch-vaginal fistulas. This is a standardised set of outcomes that should be measured and reported in all interventional studies relating specifically to these fistulae. This will allow the success or failure of interventions to be objectively assessed. We will perform a systematic review of the literature to identify the current outcomes reported in studies. We will then perform qualitative interviews with patients to understand outcomes that are relevant to patients. Patients and healthcare professionals will be recruited internationally to prioritise these outcomes using multiple web-based Delphi rounds. A face-to-face consensus meeting will be held to establish the final core outcome set.
REC name
North of Scotland Research Ethics Committee 2
REC reference
20/NS/0120
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion