Fistulectomy and Primary Sphincter rEconstruction vs. endorectaL Advancement Flap in the Treatment of High Anal Fistulas
SELF
Fistulectomy With Primary Sphincter Reconstruction vs. Muco-muscular Endorectal Advancement Flap in the Treatment of High Transsphincteric Anal Fistulas
1 other identifier
interventional
142
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2017
CompletedFirst Submitted
Initial submission to the registry
October 6, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2020
CompletedFebruary 28, 2020
February 1, 2020
2.3 years
October 6, 2019
February 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incontinence rate
The frequency of incontinence after the operation in accordance with the classification CCFF-IS (Cleveland Clinic Florida Faecal Incontinence Score). 0 points - total continence, 24 points - complete incontinence.
1 day - 1 year
Secondary Outcomes (4)
Pain intencity
1 day, 7 day, 14 day, 30 day
Recurrence rate
1 day - 1 year
Wound healing
30 day - 90 day
Overall quality of life
assessed after surgery: 14 day, 1 month, 3 month, 6 month, 1 year
Study Arms (2)
Muco-muscular endorectal advancement flap
ACTIVE COMPARATORAfter fistulectomy a muco-muscular endorectal advancement flap is mobilised and fixed to anoderma
Primary sphincter reconstruction
EXPERIMENTALAfter fistulectomy the defect in anal sphincters is closed
Interventions
After fistulectomy muco-muscular flap of the rectal wall will be mobilized. The muscular defect is sutured with separate interrupted sutures (Vicryl / Polysorb 2/0, 0/0, 3/0). The muco-muscular flap is fixed to the anoderm without tension by interrupted sutures (Vicryl / Polysorb 4/0). The wound of the perianal area is not sutured.
Fistulectomy will be performed. The affected gland is visualized and removed. If there are secondary extensions, they are excised also. Sphincter defect with stitches (suture material Vicryl / Polysorb 2/0, 0/0, 3/0) with restoration of the anal canal profile (suturing of the anodermal-skin border). The skin is not suturing.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, 119435, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Tsarkov, Prof
Russian Society of Colorectal Surgeons
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2019
First Posted
October 8, 2019
Study Start
November 4, 2017
Primary Completion
February 20, 2020
Study Completion
March 7, 2020
Last Updated
February 28, 2020
Record last verified: 2020-02