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Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Sponsor: Region Skane
Summary
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
Official title: Colon Cleansing Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2026-11-01
Completion Date
2028-11
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Mechanical bowel preparation
Oral bowel cleansing with Plenvu before surgery used within its marketing authorisation.
Locations (1)
Skane University Hospital, Pelvic Floor Centre
Malmö, Skåne County, Sweden