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Ethibond Suture vs Vessel Loop as Draining Seton for Complex Anal Fistulas

NCT05933343 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-10-20

No results posted yet for this study

Summary

Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.

Conditions

  • Anal Fistula

Interventions

PROCEDURE

Ethibond suture

An Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula

PROCEDURE

Vessel loop

A vessel loop will be placed as a drainage seton for complex anal fistula

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Steven D Wexner, M.D. · Cleveland Clinic Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-10
Primary Completion
2025-10-16
Completion
2025-10-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933343 on ClinicalTrials.gov