Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula (DADS)

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Anal Fistula

Treatments: Procedure: Decompression and drainage seton; Procedure: Cutting seton

Study type: Interventional

Funder types: Other

Identifiers

NCT05044182

2020-1-QN-10

Details and patient eligibility

About

Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from high horseshoe anal fistula

Exclusion criteria

• Specific cause of fistula e.g. Crohn's disease.
• Previous anorectal surgery.
• Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
• Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Decompression and drainage seton

Experimental group

Description:

Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter.

Treatment:

Procedure: Decompression and drainage seton

Procedure: Cutting seton

Cutting seton

Experimental group

Description:

Cutting seton will be put around the internal and external anal sphincter.

Treatment:

Procedure: Decompression and drainage seton

Procedure: Cutting seton