QOL in RVF
Research type
Research Study
Full title
Development of a patient reported outcome tool to measure the quality of life in patients with rectovaginal fistula (RVF): The vaginal fistula quality of life scale (VaF-QoL)
IRAS ID
265211
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, 30 days
Research summary
A rectovaginal (RVF) is a serious benign condition, which causes a lot of misery to the patient and challenges for the surgeon. It is an abnormal communication between the back wall of the vagina and front of the rectum. It can cause a variety of symptoms, such as the uncontrolled passage of wind and stool through the vagina, recurrent urinary tract infections, discharge and painful sex. It can be caused from obstetric injury, Crohn's disease, infection and also result of a complication from other types of surgery. It is incredibly rare, which makes it difficult to build expertise to eventually cure the condition.
RVF is difficult to treat and the heterogeneity, small study numbers and lack of guidelines makes definitive curable intervention difficult. The fistulae often require many interventions to eventually cure the condition. In some circumstances the fistula may never close. It is important to measure what a successful outcome is in these groups of patients and it is necessary to measure how different treatment strategies has an impact on quality of life.
There is currently no disease specific quality of life patient reported outcome tool for RVF. We aim to develop a tool that can be used to document patient reported outcomes in RVF. This will be patient centred. We will employ qualitative research techniques, which involve patient experience interviews, with patients with a diagnosis of RVF or who have been previously diagnosed. We will also involve a group of healthcare professionals with experience within this field. They will be used to reach a consensus opinion through three phases. This technique has been previously employed by members in the research team to develop a quality of life questionnaire.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0502
Date of REC Opinion
5 Nov 2019
REC opinion
Further Information Favourable Opinion