Surgical Treatment of a Chronic Anal Fissure (STCAF)

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