A rectovaginal fistula (RVF) is an abnormal communication between the vagina and the anus or rectum. This results in distressing symptoms such as the uncontrolled passage of stool and flatus through the vagina, and psychological impairment. An RVF can be caused by obstetric trauma, Crohn’s disease, malignancy, iatrogenic injury and exposure to radiotherapy. This condition is very rare and it is difficult to build expertise within this field, and reports in the literature often reflects the surgeon’s personal experience.
Innovations in RVF have led to a plethora of techniques such as advancement flap, and tissue interposition, including Martius flap and omentoplasty. To date there is no widely used, reproducible, objective measure for clinicians to assess the effectiveness of RVF treatment. Outcome measurement tends to focus on fistula healing/ persistence and rarely include patient reported outcome measures or quality of life assessment. The lack of standardised outcome measures impairs the comparison of treatment strategies, hampers effective analysis and comparison of data. The development of a core outcome set will help to solve this problem and ensure that the outcomes developed from this study will be the minimum requirement to be reported in any given study regarding RVF treatment. More importantly commonly reported outcomes are usually determined by healthcare professionals and may not be meaningful to patients. Both healthcare professionals and patients will be involved in this study.
The aim of this study is to develop a core outcome set regarding the outcome of treatment for an RVF.
Charlene Sackitey (TB) – St Mark’s Hospital
Mr Phil Tozer – St Mark’s Hospital
Disease Category: Pregnancy & childbirth, Cancer, Gastroenterology, Gynaecology
Disease Name: Rectovaginal fistula
Age Range: 18
Nature of Intervention: Surgery
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Consensus meeting
- Delphi process
- Systematic review
Phase 1: A systematic literature review and semi-structured patient interviews will be conducted to generate a long list of outcomes and categorised into domains. This will also include definitions, outcome measurement instruments and timing of outcome assessment.
Phase 2: Stakeholders (including patients with RVF, surgeons, gastroenterologists, gynaecologists, radiologists, and inflammatory bowel disease specialist nurses) will be presented with the domains via a web - based Delphi system to assess the importance of each candidate outcome. Participants will be asked to score each outcome on a nine-point Likert scale based on how important they felt the overall treatment was on RVF. Over three rounds, consensus develops around the most important outcomes.
Phase 3: A face to face consensus meeting with all the stakeholders will be used to finalise and ratify the core outcome set.