Chronic Anal Fissure
Conditions
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.
Interventions
OTHERlateral 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.
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anal sphincter insufficiency | 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
| Measure | Time frame | Description |
|---|---|---|
| 2-item pain intensity (P2) | On day 7, 30 and 60 | 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). |
| Non-Healing Wound | On day 60 | Frequency of post-operative wound epithelialization |
| Profilometry /sphincterometry findings | On day 30 and 60 | Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry |
| Temporary disability | Up to 60 days | Duration of temporary disability |
| Relap | Up to 60 days | Frequency of relapses |
Countries
Russia
Outcome results
None listed