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Completed

NCT Number: NCT05087407

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

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.

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Key information

Conditions

High Complex Anal Fistula

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decomprssion and drainage seton

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

Procedure

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Oct 21, 2021
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.