Back to resultsDecompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula (DADS)
Primary Purpose
Anal Fistula
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Decompression and drainage seton
Cutting seton
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula
Eligibility Criteria
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.
Sites / Locations
- China-Japan friendshipRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Decompression and drainage seton
Cutting seton
Arm Description
Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter.
Cutting seton will be put around the internal and external anal sphincter.
Outcomes
Primary Outcome Measures
Recurrence rate
recurrence was defined as the clinical reappearance of the fistula after complete healing.
Secondary Outcome Measures
Full Information
NCT ID
NCT05044182
First Posted
September 5, 2021
Last Updated
February 15, 2023
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05044182
Brief Title
Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula
Acronym
DADS
Official Title
Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decompression and drainage seton
Arm Type
Experimental
Arm Description
Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter.
Arm Title
Cutting seton
Arm Type
Experimental
Arm Description
Cutting seton will be put around the internal and external anal sphincter.
Intervention Type
Procedure
Intervention Name(s)
Decompression and drainage seton
Intervention Description
Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.
Intervention Type
Procedure
Intervention Name(s)
Cutting seton
Intervention Description
Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.
Primary Outcome Measure Information:
Title
Recurrence rate
Description
recurrence was defined as the clinical reappearance of the fistula after complete healing.
Time Frame
12 months after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Li, bachelor
Phone
0861084206250
Email
358219241@qq.com
Facility Information:
Facility Name
China-Japan friendship
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Li, bachelor
Phone
+861084206250
Email
358219241@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula
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