Assessment of the efficacy of the rectovaginal button fistula plug for the treatment of ileal pouch-vaginal and rectovaginal fistulas.

BACKGROUND: The treatment of rectovaginal and ileal pouch-vaginal fistulas remains a challenging problem for the colorectal surgeon. The aim of this study was to assess the short-term efficacy of the new Surgisis Biodesign rectovaginal button fistula plug in patients with such fistulas.

METHODS: Between May 2008 and September 2008, patients with confirmed rectovaginal and ileal pouch-vaginal fistulas with backgrounds of inflammatory bowel disease were treated with the button fistula plug. The fistulas were assessed by magnetic resonance imaging and/or examination under anesthesia before the procedure.

RESULTS: Twelve patients with a median age of 36 (range, 29-42) years underwent a total of 20 plug insertions. Five patients had confirmed rectovaginal fistulas and seven patients had ileal pouch-vaginal fistulas. At a median follow-up of 15 (interquartile range, 10-21) weeks, 7 of 12 patients (58%) had been treated successfully. Seven of the 20 plugs that were inserted (35%) were successful. This equates to the successful treatment of three of five (60%) of the rectovaginal fistulas, and four of seven (57%) of the ileal pouch-vaginal fistulas. Of the six patients who initially failed, a repeat procedure was performed of which one was successful. Two patients underwent a third repeat procedure, which was again unsuccessful in both cases. The success rate of these eight repeat plug insertions was therefore 12.5%. All plug failures were the result of dislodgement of the plug. There was no morbidity in our series.

CONCLUSIONS: The new button fistula plug successfully treated 7 of 12 (58%) rectovaginal and ileal pouch-vaginal fistulas.