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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| main group | Experimental | Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. |
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| control group | Experimental | In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lateral subcutaneous sphincterotomy | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSCCRussia | Recruiting | Moscow | 123423 | Russia |
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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.
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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 |
| Nikolay Goloktionov | Recruiting | Moscow | Russia |
|