Developing a pouch anal and vaginal fistula quality of life scale -V1
Research type
Research Study
Full title
Development of a patient reported outcome measure for Quality of Life in patients with a Pouch Anal or Vaginal Fistula (PAVF-QoL)
IRAS ID
288665
Contact name
Philip 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
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 ileum to create a reservoir which performs a similar function to the rectum. The ileal ’reservoir’ is then joined 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. An abnormal tunnel known as a fistula may develop between the pouch and the surrounding structures in 4.5% of patients. The most common fistulas are pouch anal and pouch vaginal fistulas. These fistulas can cause significant pain and discharge leading to a considerable impact on quality of life. They are incredibly challenging to treat and in the absence of a gold standard of management, patients are often subjected to multiple surgical interventions with the aim of healing the fistula. In the presence of such a fistula, the rate of pouch failure approaches 30%. This occurs when treatment to heal the fistula fails and the patient eventually opts for removal of pouch or a stoma.\n\nWe have very little understanding of the impact on social, psychological and general well being of these fistulas on the patient. There are no disease specific patient reported outcome measures available to objectively assess the impact of the fistula and the impact of the various surgical treatments available to the patient. Pouch function needs to be taken into consideration when surgical management is offered for the fistula, as surgical treatment aimed at fistula healing, may cause considerable pouch dysfunction. A validated QoL tool which is disease specific will be incredibly useful in decision making for surgical treatment and assessing outcomes of treatment.
REC name
Wales REC 3
REC reference
20/WA/0308
Date of REC Opinion
19 Nov 2020
REC opinion
Favourable Opinion