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

Anal Fistula Clinical Trial

— SELF  

Official title:

Fistulectomy With Primary Sphincter Reconstruction vs. Muco-muscular Endorectal Advancement Flap in the Treatment of High Transsphincteric Anal Fistulas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04119700
• Other study ID #: 070819
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2017
• Est. completion date: March 7, 2020

Study information

• Verified date: February 2020
• Source: Russian Society of Colorectal Surgeons
• Contact: Yuliia Churina, MD
• Phone: +79154970361
• Email: churina.1238[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: March 7, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Clinic of Colorectal and Minimally Invasive Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain intencity	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).	1 day, 7 day, 14 day, 30 day
Secondary	Recurrence rate	The frequency of recurrence of the disease in the comparison groups during the observation period.	1 day - 1 year
Secondary	Wound healing	The duration of wound healing in the perianal area and anus	30 day - 90 day
Secondary	Overall quality of life	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.	assessed after surgery: 14 day, 1 month, 3 month, 6 month, 1 year