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NCT05044182 Clinical Trial

Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

Anal Fistula Clinical Trial

— DADS  

Official title:
Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05044182
Other study ID # 2020-1-QN-10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 8, 2021
Est. completion date January 31, 2024

Study information
Verified date February 2023
Source China-Japan Friendship Hospital
Contact Hui Li, bachelor
Phone 0861084206250
Email 358219241@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 92
Est. completion date January 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Decompression and drainage seton
Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.
• Cutting seton
Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.

Locations
Country Name City State
China China-Japan friendship Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence rate recurrence was defined as the clinical reappearance of the fistula after complete healing. 12 months after the procedure
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