Clinical trial NCT04119700: Fistulectomy and Primary Sphincter rEconstruction vs. endorectaL Advancement Flap in the Treatment of High Anal Fistulas
Official title: Fistulectomy With Primary Sphincter Reconstruction vs. Muco-muscular Endorectal Advancement Flap in the Treatment of High Transsphincteric Anal Fistulas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Keywords: fistulectomy
fistula
advancement flap
transsphincteric fistula
sphincteroplasty
primary sphincter reconstruction
high fistula
endorectal flap
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incontinence rate
timeFrame: 1 day - 1 year
Secondary outcomes:
measure: Pain intencity
timeFrame: 1 day, 7 day, 14 day, 30 day
measure: Recurrence rate
timeFrame: 1 day - 1 year
measure: Wound healing
timeFrame: 30 day - 90 day
measure: Overall quality of life
timeFrame: assessed after surgery: 14 day, 1 month, 3 month, 6 month, 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Colorectal and Minimally Invasive Surgery
Study officials:
affiliation: Russian Society of Colorectal Surgeons
name: Petr Tsarkov, Prof
role: PRINCIPAL_INVESTIGATOR
References: