Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula
Not Applicable
Recruiting
- Conditions
- Anal Fistula
- Interventions
- Procedure: Decompression and drainage setonProcedure: Cutting seton
- 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
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
- Arm && Interventions
Group Intervention Description Cutting seton Cutting seton Cutting seton will be put around the internal and external anal sphincter. Decompression and drainage seton Decompression and drainage seton Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter. Decompression and drainage seton Cutting seton Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter. Cutting seton Decompression and drainage seton Cutting seton will be put around the internal and external anal sphincter.
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
China-Japan friendship
🇨🇳Beijing, Beijing, China