Surgical Treatment of a Chronic Anal Fissure

Not Applicable

• Conditions: Chronic Anal Fissure
• Interventions: Other: lateral subcutaneous sphincterotomy

• Registration Number: NCT05117697
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Brief Summary

This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.

Detailed Description

A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and able-bodied adults, so the issue of treatment is of particular relevance.

The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy.The investigators plan to treat a chronic anal fissure by performing a lateral subcutaneous sphincterotomy, without excision of the fissure.

Study Timeline

• Study First Submitted: 2021-09-07
• Status Verified: 2021-11
• Study Start: 2021-11-01
• Study First Submitted QC: 2021-11-03
• Last Update Submitted: 2021-11-03
• Study First Posted: 2021-11-11
• Last Update Posted: 2021-11-11
• Primary Completion: 2022-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with chronic anal fissure

Exclusion Criteria

• Inflammatory diseases of the colon
• Pectenosis
• Previous surgical interventions on the anal canal
• IV grade internal and external hemorrhoids
• Rectal fistula
• Severe somatic diseases at the decompensation stage
• Pregnancy and lactation
• Anal sphincter insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
main group	lateral subcutaneous sphincterotomy	Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy.
control group	lateral subcutaneous sphincterotomy	In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.

Primary Outcome Measures

Name	Time	Method
Anal sphincter insufficiency	Up to 60 days	Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).

Secondary Outcome Measures

Name	Time	Method
Temporary disability	Up to 60 days	Duration of temporary disability
2-item pain intensity (P2)	On day 7, 30 and 60	Self reported pain intensity after the defecation and during the day after the surgical intervention. Each item is scored 0-10 (0 = no pain; 10 = pain as bad, as can can be).
Non-Healing Wound	On day 60	Frequency of post-operative wound epithelialization
Profilometry /sphincterometry findings	On day 30 and 60	Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Relap	Up to 60 days	Frequency of relapses

Trial Locations

Locations (2)

Nikolay Goloktionov; 🇷🇺 Moscow, Russian Federation

SSCCRussia; 🇷🇺 Moscow, Russian Federation