Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula


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

  • 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

Primary 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

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China-Japan Friendship Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hui Li, Doctor – China-Japan Friendship Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.