Study Stopped
Unable to recruit the required number of patients as per the sample size calculated
Ethibond Suture vs Vessel Loop as Draining Seton for Complex Anal Fistulas
Ethibond Suture Compared to Vessel Loop as Draining Seton for Complex Anal Fistulas; a Multicenter Randomized Clinical Trial
1 other identifier
interventional
2
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedStudy Start
First participant enrolled
December 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2025
CompletedOctober 20, 2025
October 1, 2025
1.9 years
June 28, 2023
October 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Drainage of perianal sepsis
Change in the perianal disease activity index
3 and 12 months
Durability
Incidence and timing of seton break/fall
within 12 months
Secondary Outcomes (3)
Quality of life score
3 and 12 months
Healing
12 months
Continence state
12 months
Study Arms (2)
Ethibond suture
ACTIVE COMPARATORPatients with complex anal fistula will undergo placement of Ethibond™ 1 suture as a drainage seton
Vessel loop
ACTIVE COMPARATORPatients with complex anal fistula will undergo placement of vessel loop as a drainage seton
Interventions
An Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula
A vessel loop will be placed as a drainage seton for complex anal fistula
Eligibility Criteria
You may qualify if:
- Adult patients aged 18 years or older of either sex who present with CAF will be included. Both cryptoglandular fistulas and fistulas secondary to inflammatory bowel disease (IBD)
You may not qualify if:
- Simple anal fistulas
- Fistulas secondary to malignancy or irradiation therapy
- Pregnant women
- Patients with pre-existing setons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Florida
Weston, Florida, 33331, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steven D Wexner, M.D.
Cleveland Clinic Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project Scientist
Study Record Dates
First Submitted
June 28, 2023
First Posted
July 6, 2023
Study Start
December 10, 2023
Primary Completion
October 16, 2025
Study Completion
October 16, 2025
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share