TerminatedNot Applicable

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

Stopped: Unable to recruit the required number of patients as per the sample size calculated

United States2 participantsStarted 2023-12-10

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Simple anal fistulas * Fistulas secondary to malignancy or irradiation therapy * Pregnant women * Patients with pre-existing setons

What they're measuring

Drainage of perianal sepsis

Timeframe: 3 and 12 months

Durability

Timeframe: within 12 months

Trial details

NCT IDNCT05933343

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-16

View on ClinicalTrials.gov More Anal Fistula trials