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

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.

Study Overview

• Status: Completed
• Conditions: High Complex Anal Fistula
• Intervention / Treatment: Procedure: Cutting seton; Procedure: Decomprssion and drainage seton

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (ACTUAL): October 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: No.2016-81

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No