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Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05087407
Recruitment Status : Completed
First Posted : October 21, 2021
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Hui Li, China-Japan Friendship Hospital

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.

Condition or disease Intervention/treatment Phase
High Complex Anal Fistula Procedure: Decomprssion and drainage seton Procedure: Cutting seton Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cutting Seton Versus Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: decomprssion and drainage seton Procedure: Decomprssion 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.

Active Comparator: Cutting seton Procedure: Cutting seton
Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.




Primary Outcome Measures :
  1. Rate of healing [ Time Frame: 6 months post-operation. ]
    complete healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge under physical examination.

  2. Recurrence rate [ Time Frame: within 12 months after the procedure ]
    recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton

  3. The healing time of the anal wound (days) [ Time Frame: 6 months post-operation. ]
    the time needed to achieve complete healing of anal fistula.



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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087407


Locations
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China, Beijing
China-Japan friendship Hospital
Beijing, Beijing, China, 100029
Sponsors and Collaborators
China-Japan Friendship Hospital
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Responsible Party: Hui Li, Associate chief physician, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT05087407    
Other Study ID Numbers: No.2016-81
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases