Device for occlusion of rectovaginal fistula

Clinical trials

Byung Hee Lee, Du Hwan Choe, Jeong Hoon Lee, Kie Hwan Kim, Dae Yong Hwang, Sang Yoon Park, Chul Koo Cho, Soo Yil Chin

Research output: Contribution to journalArticleResearchpeer-review

5 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)65-69
Number of pages5
JournalRadiology
Volume203
Issue number1
DOIs
StatePublished - 1 Jan 1997

Fingerprint

Rectovaginal Fistula
Clinical Trials
Equipment and Supplies
Medicago
Nylons
Silicones
Fistula
Neoplasm Metastasis

Keywords

  • Fistula, rectovaginal
  • Fistula, therapeutic blockade
  • Interventional procedures, technology

Cite this

Lee, B. H., Choe, D. H., Lee, J. H., Kim, K. H., Hwang, D. Y., Park, S. Y., ... Chin, S. Y. (1997). Device for occlusion of rectovaginal fistula: Clinical trials. Radiology, 203(1), 65-69. https://doi.org/10.1148/radiology.203.1.9122417
Lee, Byung Hee ; Choe, Du Hwan ; Lee, Jeong Hoon ; Kim, Kie Hwan ; Hwang, Dae Yong ; Park, Sang Yoon ; Cho, Chul Koo ; Chin, Soo Yil. / Device for occlusion of rectovaginal fistula : Clinical trials. In: Radiology. 1997 ; Vol. 203, No. 1. pp. 65-69.
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Lee, BH, Choe, DH, Lee, JH, Kim, KH, Hwang, DY, Park, SY, Cho, CK & Chin, SY 1997, 'Device for occlusion of rectovaginal fistula: Clinical trials', Radiology, vol. 203, no. 1, pp. 65-69. https://doi.org/10.1148/radiology.203.1.9122417

Device for occlusion of rectovaginal fistula : Clinical trials. / Lee, Byung Hee; Choe, Du Hwan; Lee, Jeong Hoon; Kim, Kie Hwan; Hwang, Dae Yong; Park, Sang Yoon; Cho, Chul Koo; Chin, Soo Yil.

In: Radiology, Vol. 203, No. 1, 01.01.1997, p. 65-69.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Lee, Byung Hee

AU - Choe, Du Hwan

AU - Lee, Jeong Hoon

AU - Kim, Kie Hwan

AU - Hwang, Dae Yong

AU - Park, Sang Yoon

AU - Cho, Chul Koo

AU - Chin, Soo Yil

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N2 - 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.

AB - 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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