Surgical Treatment of a Chronic Anal Fissure

State Scientific Centre of Coloproctology, Russian Federation120 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Chronic Anal Fissure

Interventions

lateral subcutaneous sphincterotomyOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

SSCCRussia

Moscow, Russia

RECRUITING

Nikolay Goloktionov

Moscow, Russia

RECRUITING

Outcomes

Primary Outcomes

Anal sphincter insufficiency

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).

Time frame: Up to 60 days

Secondary Outcomes

2-item pain intensity (P2)

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).

Time frame: On day 7, 30 and 60

Non-Healing Wound

Frequency of post-operative wound epithelialization

Time frame: On day 60

Profilometry /sphincterometry findings

Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry

Time frame: On day 30 and 60

Temporary disability

Duration of temporary disability

Time frame: Up to 60 days

Relap

Frequency of relapses

Time frame: Up to 60 days

Data from ClinicalTrials.gov

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