Bowel cleansing before surgery for complex anal fistula, including fistulas linked to Crohn disease
Tests bowel preparation before surgery for complex anal fistula in adults.
Plain-language title generated from the registry record
Registry title: Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Key facts
- Where
- Malmö, SwedenSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07897539, who can take part
Where in Sweden
- Skane University Hospital, Pelvic Floor CentreMalmö, SwedenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Skane
- Trial code
- NCT07897539
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
Colon Cleansing Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
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
Inclusion: 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.
Exclusion: Patients who have previously experienced allergic reactions to NER1006 or any of its chemical components; 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; Patients aged < 18 years; Pregnant patients; Complex fistulae associated with cavities and/or secondary tracts; Patients with ASA classification of IV or higher.