Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula

China-Japan Friendship Hospital

Status: Completed

Conditions: High Complex Anal Fistula

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05087407

No.2016-81

Details and patient eligibility

About

This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.

Enrollment: 120 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• high trans-sphincteric cryptoglandular anal fistulas (involving >30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography)
• suprasphincteric fistulas were enrolled

Exclusion criteria

• Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; -
• Patients with symptoms of fecal incontinence;
• A previous history of anal fistula surgical treatment;
• Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

decomprssion and drainage seton

Experimental group

Treatment:

Procedure: Decomprssion and drainage seton

Cutting seton

Active Comparator group

Treatment:

Procedure: Cutting seton