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

NCT04119700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2020-02-28

No results posted yet for this study

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.

Conditions

  • Anal Fistula

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Russian Society of Colorectal Surgeons

    lead OTHER

Principal Investigators

  • Petr Tsarkov, Prof · Russian Society of Colorectal Surgeons

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-04
Primary Completion
2020-02-20
Completion
2020-03-07

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04119700 on ClinicalTrials.gov