Status:
UNKNOWN
Fistulectomy and Primary Sphincter rEconstruction vs. endorectaL Advancement Flap in the Treatment of High Anal Fistulas
Lead Sponsor:
Russian Society of Colorectal Surgeons
Conditions:
Anal Fistula
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 p...
Detailed Description
Anorectal fistula is a common proctological disease with prevalence between 8.6 and 10 per 100,000 population. Surgical treatment of complex anorectal fistulas has two main objectives: preventing the ...
Eligibility Criteria
Inclusion
- 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
- 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)
- The presence of an acute purulent process in the perianal area.
- Anterior anorectal fistula in female.
- The inability to perform MRI of the pelvic organs.
Key Trial Info
Start Date :
November 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2020
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04119700
Start Date
November 4 2017
End Date
March 7 2020
Last Update
February 28 2020
Active Locations (1)
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1
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, Russia, 119435