Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

Not Applicable

Recruiting

• Conditions: Anal Fistula

• Registration Number: NCT05044182
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-05
• Study First Submitted QC: 2021-09-05
• Study First Posted: 2021-09-14
• Study Start: 2021-10-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence rate	12 months after the procedure	recurrence was defined as the clinical reappearance of the fistula after complete healing.

Trial Locations

Locations (1)

China-Japan friendship; 🇨🇳 Beijing, Beijing, China