Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

Overview

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

Interventions

  • 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

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