Prospective randomized comparison of repairing vesicovaginal fistula with or without the interposition flap: Result from a tertiary care Institute in Northern India.

OBJECTIVE: Assessment of results of repairing vesicovaginal fistula (VVF) with or without the use of interposition flaps.
MATERIAL AND METHODS: This prospective randomized study was conducted between January 2012 to December 2017 in the Department of Urology, King George's Medical University, Lucknow, India. Obstetric and gynecological simple fistula of ≤4 cm were included for evaluation. Those with complex or complicated fistula or fistula due to malignancy were excluded. Patients were divided into two groups (group 1 and group 2) depending upon route of repair i.e., transvaginal or transabdominal, respectively, as per the characteristics and location of the fistula. These two groups of patients were randomized into two subgroups (1A, 1B and 2A, 2B) based on the inclusion or omission of the interposition flap during fistula repair. Perioperative and postoperative parameters (blood loss, mean operating time, hospital stay, and requirement of analgesics) and success rates of fistula repair were compared. All complications that occurred in the postoperative period till the last follow-up appointment were recorded. The Clavien-Dindo Classification was used to stratify the complications.
RESULTS: Fifty-seven patients underwent transvaginal repair in group 1 (29 with Martius flap: group 1A; 28 without Martius flap: group 1B), while 69 patients underwent transabdominal repair in group 2 (35 with interposition flap: group 2A; 34 without flap: group 2B). Blood loss, mean operating time, hospital stay, and the requirement of analgesics were comparable between each subgroup-1A versus 1B and 2A versus 2B, respectively. The overall success rate of repair across all groups was 96.04% (121/126). The success rate was 93.1% in transvaginal repair with Martius flap versus 96.43% in transvaginal repair with no flap (p=1.0). Success rate was 97.1% in transabdominal repair with an omental flap versus 97.06% in without an omental flap (p=1.0). Mean follow-up period was 39.6 months (range: 6-68 months). Out of 29 patients with Martius flap interposition, 9 (31.03%) of them reported a significantly reduced sensation on the labia majora. Of these 9 patients, 5 reported numbness while the remaining 4 experienced pain as compared to the patients in subgroup IB, who did not report any altered sensation in the labia. (p=0.0019).
CONCLUSION: The success rates are similar in simple VVF repair (fistula size less than 4 cm) irrespective of the use of interposition flaps. However, overall morbidities following repair with the interposition flap are higher when compared with repair without interposition flap, either by the transvaginal or by the transabdominal route.

RCT Entities:   Population Interventions Outcomes