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.
Full Title of Study: “Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: December 31, 2023
- 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.
- Procedure: Cutting seton
- Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.
Arms, Groups and Cohorts
- Experimental: Decompression and drainage seton
- Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter.
- Experimental: Cutting seton
- Cutting seton will be put around the internal and external anal sphincter.
Clinical Trial Outcome Measures
- Recurrence rate
- Time Frame: 12 months after the procedure
- recurrence was defined as the clinical reappearance of the fistula after complete healing.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- China-Japan Friendship Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Hui Li, Doctor – China-Japan Friendship Hospital
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