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NOT YET RECRUITING
NCT07897539
NA

Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae

Sponsor: Region Skane

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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