Loose Seton Prior to Surgery for Single-tract Cryptoglandular Fistula vs no Seton

NCT07807319 | Recruiting

• 1 other identifier: NL-010338
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 2

Brief Summary

Cryptoglandular anal fistulas can cause pain, discharge, recurrent infection, and a prolonged treatment course. In current practice, patients with a single-tract mid-high or high cryptoglandular anal fistula often first undergo placement of a loose seton before definitive sphincter-preserving surgery. Although this staged approach is widely used, high-quality evidence showing that preoperative seton placement improves healing or other patient outcomes is limited. The SETON trial is a multicenter, randomized, controlled non-inferiority trial that compares two accepted treatment strategies: loose seton placement for approximately 8 weeks followed by definitive sphincter-preserving surgery versus direct sphincter-preserving surgery without prior seton placement. The study aims to determine whether omitting routine seton placement is not inferior in terms of fistula closure 26 weeks after the final surgical intervention. Secondary outcomes include recurrence, postoperative complications, re-interventions, pain, continence, fistula-related quality of life, generic quality of life, return to work, and healthcare and societal costs. The results of this trial may help determine whether a routinely used treatment step can be safely omitted, potentially reducing treatment burden, shortening the treatment pathway, and lowering costs.

Conditions

Cryptoglandular Perianal Fistula

Outcome Measures

Primary Outcomes (1)

• Fistula healing

  Fistula closure is defined as absence of an external opening or discharge on physical examination 26 weeks after the final surgical intervention. In case of clinical uncertainty, closure will be confirmed by magnetic resonance imaging (MRI) or endoanal ultrasound.

  26 weeks

Study Arms (2)

Seton placement prior to surgery

NO INTERVENTION

No seton placement prior to surgery

EXPERIMENTAL

Procedure: No seton placement prior to surgery

Interventions

No seton placement prior to surgery PROCEDURE

No seton placement prior to sfincter preserving surgery

No seton placement prior to surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Proctos Kliniek: lead

Study Sites (2)

Ziekenhuis Amstelland

Amstelveen, North Holland, 1186 AM, Netherlands

RECRUITING

Proctos Kliniek

Bilthoven, North Holland, 3723 MB, Netherlands

RECRUITING

Central Study Contacts

Ahmed Elwakel, MD

CONTACT

+31613489317; a.elwakel@proctoskliniek.nl

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: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: September 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months embargo due to publishing.
• Access Criteria: There will be access restrictions to my data collection. A request must be made at Data Access Committee (DAC).

Locations

NL (2)