SETON study
Research type
Research Study
Full title
Comparative analysis of patient comfort using silastic versus ethibond setons: an observational cohort study (feasibility study)
IRAS ID
347031
Contact name
Phil Tozer
Contact email
Sponsor organisation
London North West University NHS Trust
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
Setons are medical threads placed in a fistula tract to help drain infection and promote healing. This study will include patients who already have a seton due to a fistula that occurred on it's own, or due to Crohn's disease or ulcerative colitis.
Patients will be monitored over a 4-month period while keeping their current seton. During this time, assessments will track comfort levels, abscess formation, seton displacement, and any need for antibiotics or additional procedures. Each week, patients will complete a diary card to record a 'forgotten seton score', reflecting how often they are aware of or bothered by their seton in daily life.
After the initial 4-month period, patients will switch to a different seton type (silastic or ethibond), and undergo another 4 month period of monitoring with the same assessments. Photographs of the setons will be taken during each phase. Patients will also provide feedback on their seton preferences.
The primary goal is to evaluate the feasibility of running this study in the form of a larger scale randomised crossover trial in the future. This will be measured by the ability to recruit patients, track their progress effectively, and ensure patients can complete diary entries and comfort assessments. The results will help determine which seton type is more comfortable and practical for long-term use.
REC name
Wales REC 6
REC reference
25/WA/0015
Date of REC Opinion
14 Feb 2025
REC opinion
Further Information Favourable Opinion