Back to resultsDecompression and Drainage Seton in the Treatment of High Complex Anal Fistula
Primary Purpose
High Complex Anal Fistula
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Decomprssion and drainage seton
Cutting seton
Sponsored by
About this trial
This is an interventional treatment trial for High Complex Anal Fistula
Eligibility Criteria
Inclusion Criteria:
- high trans-sphincteric cryptoglandular anal fistulas (involving >30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography)
- suprasphincteric fistulas were enrolled
Exclusion Criteria:
- Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; -
- Patients with symptoms of fecal incontinence;
- A previous history of anal fistula surgical treatment;
- Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
Sites / Locations
- China-Japan friendship Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
decomprssion and drainage seton
Cutting seton
Arm Description
Outcomes
Primary Outcome Measures
Rate of healing
complete healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge under physical examination.
Recurrence rate
recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton
The healing time of the anal wound (days)
the time needed to achieve complete healing of anal fistula.
Secondary Outcome Measures
Full Information
NCT ID
NCT05087407
First Posted
October 12, 2021
Last Updated
October 22, 2021
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05087407
Brief Title
Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
Official Title
Cutting Seton Versus Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Complex Anal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
decomprssion and drainage seton
Arm Type
Experimental
Arm Title
Cutting seton
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Decomprssion 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
Rate of healing
Description
complete healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge under physical examination.
Time Frame
6 months post-operation.
Title
Recurrence rate
Description
recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton
Time Frame
within 12 months after the procedure
Title
The healing time of the anal wound (days)
Description
the time needed to achieve complete healing of anal fistula.
Time Frame
6 months post-operation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high trans-sphincteric cryptoglandular anal fistulas (involving >30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography)
suprasphincteric fistulas were enrolled
Exclusion Criteria:
Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; -
Patients with symptoms of fecal incontinence;
A previous history of anal fistula surgical treatment;
Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
Facility Information:
Facility Name
China-Japan friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
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