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

NCT ID: NCT05087407

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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High Complex Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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decomprssion and drainage seton

Group Type EXPERIMENTAL

Decomprssion and drainage seton

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Cutting seton

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Cutting seton

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hui Li

Associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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No.2016-81

Identifier Type: -

Identifier Source: org_study_id