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Surgical Treatment of a Chronic Anal Fissure (STCAF)

S

State Scientific Centre of Coloproctology, Russian Federation

Status

Unknown

Conditions

Chronic Anal Fissure

Treatments

Other: lateral subcutaneous sphincterotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05117697
56IG701SSCC977

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

main group
Experimental group
Description:
Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy.
Treatment:
Other: lateral subcutaneous sphincterotomy
control group
Experimental group
Description:
In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.
Treatment:
Other: lateral subcutaneous sphincterotomy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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