Fistulectomy and Primary Sphincter rEconstruction vs. endorectaL Advancement Flap in the Treatment of High Anal Fistulas
NCT ID: NCT04119700
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
142 participants
INTERVENTIONAL
2017-11-04
2020-03-07
Brief Summary
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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.
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Detailed Description
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Many methods are used for high anorectal fistula's treatment, but the optimal strategy has not been found yet.
Nowadays, the conventional sphincter-preserving operation for the treatment of complex anorectal fistulas is advancement rectal flap. In addition, plastic with a full-thickness flap in comparison with a mucosal flap was associated with less reccurence rate (10% and 40% respectively), and was accompanied by manifestation of incontinence symptoms, increased with the thickness of the flap.
About 20 years ago, in an attempt to reduce high level of incontinence, the primary reconstruction of sphincters after fistulotomy was proposed; however, this technique is still debated.
According to reports, dissection of more than 1/3 of the sphincter increases the incidence of postoperative incontinence. However, fistulectomy with primary suturing of the sphincter defect allows to improve the function of anal continence and is recommended for patients with initial incontinence after previous surgical interventions.
The studie's aim is comparison between 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Muco-muscular endorectal advancement flap
After fistulectomy a muco-muscular endorectal advancement flap is mobilised and fixed to anoderma
Muco-muscular endorectal advancement flap after fistulectomy
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.
Primary sphincter reconstruction
After fistulectomy the defect in anal sphincters is closed
Primary sphincter reconstruction after fistulectomy
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.
Interventions
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Muco-muscular endorectal advancement flap after fistulectomy
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.
Primary sphincter reconstruction after fistulectomy
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
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Inclusion Criteria
2. Patient's consent for surgery
3. 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
4. Cryptoglandular fistulas
5. The absence of incontinence before the operation in accordance with the classification CCFF-IS
6. Preoperative MR-diagnostics before the operation
Exclusion Criteria
2. Low transsphincteric (involving less than 1/3 of the height of the sphincter according to MRI), intersphincteric, extrasphincteric fistula of the rectum.
3. Recurrent fistula.
4. Rectovaginal or rectourethral fistula.
5. Anal incontinence (Appendix 2).
6. Pregnancy.
7. Inflammatory bowel disease (confirmed endoscopically and morphologically).
8. Patients with immunodepression (i.e. HIV)
9. The presence of an acute purulent process in the perianal area.
10. Anterior anorectal fistula in female.
11. The inability to perform MRI of the pelvic organs.
18 Years
70 Years
ALL
No
Sponsors
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Russian Society of Colorectal Surgeons
OTHER
Responsible Party
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Principal Investigators
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Petr Tsarkov, Prof
Role: PRINCIPAL_INVESTIGATOR
Russian Society of Colorectal Surgeons
Locations
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Clinic of Colorectal and Minimally Invasive Surgery
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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070819
Identifier Type: -
Identifier Source: org_study_id
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