Surgical Treatment of a Chronic Anal Fissure

Chronic Anal Fissure Clinical Trial

— STCAF  

Official title:

Treatment of Chronic Anal Fissure by Performing a Lateral Subcutaneous Sphincterotomy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05117697
• Other study ID #: 56IG701SSCC977
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2021
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Anal Fissure
• Fissure in Ano

Intervention

Other:
• lateral subcutaneous sphincterotomy
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.

Locations

Country	Name	City	State
Russian Federation	Nikolay Goloktionov	Moscow
Russian Federation	SSCCRussia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 60 days
Secondary	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).	On day 7, 30 and 60
Secondary	Non-Healing Wound	Frequency of post-operative wound epithelialization	On day 60
Secondary	Profilometry /sphincterometry findings	Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry	On day 30 and 60
Secondary	Temporary disability	Duration of temporary disability	Up to 60 days
Secondary	Relap	Frequency of relapses	Up to 60 days