NCT07897539Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Colon Cleansing Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn whether bowel preparation with Plenvu before surgery improves healing of complex anal fistula in adults aged 18 to 64 years with a fistula of cryptoglandular origin or associated with Crohn's disease. The main question it aims to answer is: \- Does bowel preparation before surgery increase the proportion of participants whose fistula is clinically healed 6 months after surgery? Researchers will compare participants who prepare the bowel before surgery with participants who receive no bowel preparation. All participants receive the same oral antibiotic regimen and one of three standard sphincter-preserving operations: ligation of the intersphincteric fistula tract (LIFT), autologous platelet-rich fibrin (Obsidian), or endorectal advancement flap. The operation is chosen individually by the surgeon as the most appropriate for each fistula, before randomisation. Participants will: * Be randomly assigned to bowel preparation or no bowel preparation * Undergo one fistula operation within the study * Attend follow-up visits 6 and 12 months after surgery, including clinical examination and 3D endoanal ultrasound at 12 months after surgery * Complete questionnaires on anal continence and quality of life
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- May 2028
- Lead sponsor
- Region Skane
- Diseases
- Crohn's disease
- NCT number
- NCT07897539
What you commit to
- Study type: Interventional
- Planned participants: 116
- From 1 Nov 2026 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously experienced allergic reactions to NER1006 or any of its chemical components.
Other illness
- Fistulae with aetiologies other than cryptoglandular or Crohn's disease.
- Patients with fistulae who underwent faecal diversion before fistula surgery.
- Patients with severe conditions such as renal failure that predisposes to dehydration or hydroelectrolytic disorders.
Age
- Patients aged \< 18 years.
Other
- Pregnant patients.
- Complex fistulae associated with cavities and/or secondary tracts.
- Patients with ASA classification of IV or higher.
Who the study is looking for
- Age 18 to 64 years
- Complex anal fistula of cryptoglandular origin or associated with Crohn's disease
- Fistula suitable for repair with ligation of the intersphincteric fistula tract (LIFT), autologous platelet-rich fibrin (Obsidian) or endorectal advancement flap
- Patients with or without previous attempts at fistula closure
- Signed written informed consent
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Skane University Hospital, Pelvic Floor Centre Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.