Loose Seton Before Surgery for a Single-tract Cryptoglandular Fistula vs No Seton
Official title: Loose Seton Prior to Surgery for Single-tract Cryptoglandular Fistula vs no Seton: a Multicenter Randomised Study
Run by Proctos Kliniek · NCT07807319 · Data updated 2026-11-12
This trial tests whether skipping the preoperative loose seton before definitive fistula surgery is as good as the standard approach that uses a seton first in adults with a single-tract cryptoglandular anal fistula.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 277 (estimated) |
| Sponsor | Proctos Kliniek Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Amstelveen, North Holland and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2029 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07807319 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with a single-tract non-purulent mid-high or high cryptoglandular anal fistula eligible for sphincter-preserving surgery.
✕Probably not a fit
Patients with complex fistulas, purulent or multiple tracts, inflammatory bowel disease, pelvic radiation history, or other exclusion criteria may not benefit from the approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SETON is a multicenter randomized non-inferiority study comparing two management strategies for single-tract mid-high or high cryptoglandular anal fistulas. Participants are assigned to loose seton placement for about eight weeks followed by definitive sphincter-preserving surgery, or to proceed directly to definitive surgery without a prior seton. The trial includes an integrated cost-utility analysis to evaluate economic impact alongside clinical outcomes. Primary outcome is fistula closure 26 weeks after the final surgical intervention; secondary outcomes include recurrence and postoperative complications. Eligible participants are adults with a single-tract non-purulent fistula and suitability for sphincter-preserving surgery, recruited from multiple centers in the Netherlands.
Why it matters
Potential benefit: If non-inferiority is shown, many patients may avoid an extra procedure and reduced treatment burden without compromising fistula healing.
How similar studies have gone: Previous retrospective data offer mixed or inconclusive results; this randomized trial directly tests the preoperative seton strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Single-tract non-purulent mid-high or high cryptoglandular anal fistula * Eligible for sphincter-preserving surgical treatment * Able to complete Dutch-language questionnaires sent by email * Written informed consent provided Exclusion Criteria: * Anorectal abscess * Multiple or complex anorectal fistulas * Inflammatory bowel disease or clinical suspicion requiring further investigation * History of anorectal malignancy * Use of immunosuppressive medication at the time of surgery * History of pelvic radiation * Pregnancy or lactation
Where it's running
-
Ziekenhuis Amstelland
Amstelveen, North Holland, Netherlands Recruiting -
Proctos Kliniek
Bilthoven, North Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Ahmed Elwakel, MD
- Email: a.elwakel@proctoskliniek.nl
- Phone: +31613489317
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Perianal fistula imaging comparison using TPUS, MRI, EUS, and EUA
This study tests how well four imaging methods—transperineal ultrasound, MRI, endoscopic ultrasound, and examination under anesthesia—detect and describe perianal fistulas in adults with Crohn's disease or unknown cause.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.