Surgical Treatment of a Chronic Anal Fissure

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

Detailed Description
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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.

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

Conditions
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Chronic Anal Fissure

Intervention / Treatment
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* Other: lateral subcutaneous sphincterotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment A comparative,randomized, prospective, single-center clinical study. 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: main group<br>Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. | Other: lateral subcutaneous sphincterotomy<br>* 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.<br>|
| Experimental: control group<br>In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy. | Other: lateral subcutaneous sphincterotomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Non-Healing Wound | Frequency of post-operative wound epithelialization | On day 60 | 
| 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 | 
| Temporary disability | Duration of temporary disability | Up to 60 days | 
| Relap | Frequency of relapses | Up to 60 days |