DEVICE FOR OCCLUSION OF RECTOVAGINAL FISTULA - CLINICAL-TRIALS

PURPOSE: To evaluate a device designed for occlusion of rectovaginal f istula in patients with acquired rectovaginal fistula. MATERIALS AND M ETHODS: The device consisted of a disk portion, an anchoring portion, and a shaft that connected each portion. The device was framed with a nitinol wire. The disk portion was framed in a four-leaf clover config uration, and the anchoring portion had two ellipsoid arms. The disk an d anchoring portions were mounted with a nylon patch and coated with s ilicone. The device was designed for transrectal insertion and was pla ced in seven women with rectovaginal fistula caused by pelvic irradiat ion or pelvic surgery. RESULTS: All devices were placed successfully, and all fistulas were completely occluded after placement of the devic e. No procedural complications were encountered. The follow-up period was 1-26 months. One patient died of distant metastasis 5 months after placement of the device. None of the patients reported leakage from t he rectovaginal fistula during the follow-up period. CONCLUSION: The o cclusion device may be promising and beneficial for use in occlusion o f rectovaginal fistula that results from pelvic irradiation or pelvic surgery.