Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula (DADS)

February 15, 2023 updated by: Hui Li, China-Japan Friendship Hospital

Clinical Study of Decompression and Drainage Seton for the 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan friendship
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decompression and drainage seton
Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter.
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.
Experimental: Cutting seton
Cutting seton will be put around the internal and external anal sphincter.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 12 months after the procedure
recurrence was defined as the clinical reappearance of the fistula after complete healing.
12 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

September 5, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1-QN-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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