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

Not Applicable

• Conditions: Anal Fistula
• Interventions: Procedure: Primary sphincter reconstruction after fistulectomy; Procedure: Muco-muscular endorectal advancement flap after fistulectomy

• Registration Number: NCT04119700
• Lead Sponsor: Russian Society of Colorectal Surgeons

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.

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 recurrence of the disease and preserving the anal continence. The optimal principle of management of patients with anorectal fistulas includes a comprehensive preoperative examination with the definition of the architectonics of the fistulous tract, the identification of the internal fistulous opening, the elimination of additional tracts and cavities.

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.

Study Timeline

• Study Start: 2017-11-04
• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-06
• Study First Posted: 2019-10-08
• Status Verified: 2020-02
• Primary Completion: 2020-02-20
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28
• Study Completion: 2020-03-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Patient's consent to participate in the study
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

1. Refuse of the patient to participate in the study.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary sphincter reconstruction	Primary sphincter reconstruction after fistulectomy	After fistulectomy the defect in anal sphincters is closed
Muco-muscular endorectal advancement flap	Muco-muscular endorectal advancement flap after fistulectomy	After fistulectomy a muco-muscular endorectal advancement flap is mobilised and fixed to anoderma

Primary Outcome Measures

Name	Time	Method
Incontinence rate	1 day - 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Wound healing	30 day - 90 day	The duration of wound healing in the perianal area and anus
Recurrence rate	1 day - 1 year	The frequency of recurrence of the disease in the comparison groups during the observation period.
Overall quality of life	assessed after surgery: 14 day, 1 month, 3 month, 6 month, 1 year	Assessed with patient-reported questionnaire SF-36 (Short-form 36 Questionnaire). A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disabilityusing the SF-36 questionnaire.
Pain intencity	1 day, 7 day, 14 day, 30 day	The severity of pain in the postoperative period according to VAS score (visual analogue pain scale). Interpretation of values: no pain (0 points), mild pain (1-4 points), moderate pain (5-9 points), severe pain (10 points).

Trial Locations

Locations (1)

Clinic of Colorectal and Minimally Invasive Surgery; 🇷🇺 Moscow, Russian Federation