Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
Cutting Seton Versus Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedOctober 28, 2021
October 1, 2021
3 years
October 12, 2021
October 22, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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.
6 months post-operation.
Recurrence rate
recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton
within 12 months after the procedure
The healing time of the anal wound (days)
the time needed to achieve complete healing of anal fistula.
6 months post-operation.
Study Arms (2)
decomprssion and drainage seton
EXPERIMENTALCutting seton
ACTIVE COMPARATORInterventions
Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.
Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China-Japan friendship Hospital
Beijing, Beijing Municipality, 100029, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate chief physician
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 21, 2021
Study Start
December 1, 2016
Primary Completion
December 1, 2019
Study Completion
May 1, 2020
Last Updated
October 28, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share