UnknownNot Applicable

Fistulectomy and Primary Sphincter rEconstruction vs. endorectaL Advancement Flap in the Treatment of High Anal Fistulas

Russia142 participantsStarted 2017-11-04

Plain-language summary

The optimal method of surgical treatment of complex anorectal fistulas has not been found yet. The aim of this study is to compare two techniques in treatment of high anorectal fistulas. This study purpose to demonstrate that the fistulectomy with dissection from 1/3 to 2/3 of the height of the sphincter complex with primary suturing is technically simpler, equally effective and safe in comparison with muco-muscular endorectal advancement flap.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patient's consent to participate in the study
✓. Patient's consent for surgery
✓. High transsphincteric anorectal fistula, involving from 1/3 to 2/3 of the height of the sphincter according to the both MRI and intraoperative revision
✓. Cryptoglandular fistulas
✓. The absence of incontinence before the operation in accordance with the classification CCFF-IS
✓. Preoperative MR-diagnostics before the operation

Exclusion criteria

✕. Refuse of the patient to participate in the study.
✕. Low transsphincteric (involving less than 1/3 of the height of the sphincter according to MRI), intersphincteric, extrasphincteric fistula of the rectum.
✕. Recurrent fistula.
✕. Rectovaginal or rectourethral fistula.
✕. Anal incontinence (Appendix 2).
✕. Pregnancy.
✕. Inflammatory bowel disease (confirmed endoscopically and morphologically).
✕. Patients with immunodepression (i.e. HIV)

What they're measuring

Incontinence rate

Timeframe: 1 day - 1 year

Trial details

NCT IDNCT04119700

SponsorRussian Society of Colorectal Surgeons

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-20

Contact for this trial

Yuliia Churina, MD

+79154970361 churina.1238@mail.ru

View on ClinicalTrials.gov More Anal Fistula trials