Treatment of Chronic Anal Fissure by Performing a Lateral Subcutaneous Sphincterotomy.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Anal Fissure
- Sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Anal sphincter insufficiency
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Anal sphincter insufficiency
Time Frame: 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 Outcomes
- 2-item pain intensity (P2)(On day 7, 30 and 60)
- Non-Healing Wound(On day 60)
- Profilometry /sphincterometry findings(On day 30 and 60)
- Temporary disability(Up to 60 days)
- Relap(Up to 60 days)