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Radiology, Vol 203, 65-69, Copyright © 1997 by Radiological Society of North America

ARTICLES

Device for occlusion of rectovaginal fistula: clinical trials

BH Lee, DH Choe, JH Lee, KH Kim, DY Hwang, SY Park, CK Cho and SY Chin
Department of Radiology, Korea Cancer Center Hospital, Nowon-gu, Seoul.

PURPOSE: To evaluate a device designed for occlusion of rectovaginal fistula in patients with acquired rectovaginal fistula. MATERIALS AND METHODS: 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 configuration, and the anchoring portion had two ellipsoid arms. The disk and anchoring portions were mounted with a nylon patch and coated with silicone. The device was designed for transrectal insertion and was placed in seven women with rectovaginal fistula caused by pelvic irradiation or pelvic surgery. RESULTS: All devices were placed successfully, and all fistulas were completely occluded after placement of the device. 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 the rectovaginal fistula during the follow-up period. CONCLUSION: The occlusion device may be promising and beneficial for use in occlusion of rectovaginal fistula that results from pelvic irradiation or pelvic surgery.




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