Buccal Mucosal Grafts as a Novel Treatment for the Repair of Rectovaginal Fistulas: Protocol for an Upcoming Prospective Single-Surgeon Case Series

Background: Rectovaginal fistulas (RVFs) are abnormal communications between the rectum/anus and the vagina. They are most frequently formed a result of obstetric injury and have deleterious effects on patients' quality of life. Despite several treatment modalities, RVFs remain difficult problems to manage, and many patients fail multiple attempts at surgical repair. Buccal mucosal grafts (BMGs) may be a solution to this problem. A BMG is an oral mucosal tissue harvested from the inner cheek. There are 2 case reports that describe the successful use of BMGs in the repair of RVFs. Objective: Our objective is to validate these findings with a prospective case series while also addressing the key issues of indication, technical details, procedure safety, and short-term outcomes. Methods: A prospective single-surgeon case series will be undertaken at a university-affiliated academic tertiary care hospital in Calgary, Alberta (Canada). The estimated recruitment is between 3 and 5 patients. Patients will undergo surgical repair of their RVFs with an autologous BMG. Data on patient characteristics, fistula characteristics, and surgical variables will be collected and analyzed prospectively. The primary outcome is fistula closure. This study has been approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB20-1123). Results: Two previous case reports have described the successful use of BMGs in the repair of RVFs. We have received ethics approval to attempt to validate these findings through a prospective case series. Conclusions: RVFs cause significant patient morbidity and are difficult problems to manage. Bolstered by the successful use of BMGs in urologic surgery and the previously published case reports demonstrating success in RVFs, we believe that BMGs may be a solution to RVFs.