Device for occlusion of rectovaginal fistula: clinical trials.
OBJECTIVE
To evaluate a device designed for occlusion of rectovaginal fistula in patients with acquired rectovaginal fistula.


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.


CONCLUSIONS
The occlusion device may be promising and beneficial for use in occlusion of rectovaginal fistula that results from pelvic irradiation or pelvic surgery.
Lee
B H
BH
Department of Radiology, Korea Cancer Center Hospital, Nowon-gu, Seoul.
Choe
D H
DH
Lee
J H
JH
Kim
K H
KH
Hwang
D Y
DY
Park
S Y
SY
Cho
C K
CK
Chin
S Y
SY
D000328:Adult; D000368:Aged; D004864:Equipment and Supplies; D005260:Female; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications; D011832:Radiation Injuries; D015641:Radiography, Interventional; D012004:Rectal Neoplasms / Q000601:surgery; D012006:Rectovaginal Fistula / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D002583:Uterine Cervical Neoplasms / Q000532:radiotherapy