ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This trial could provide the first randomized evidence on whether preoperative mechanical bowel preparation improves healing after sphincter-preserving surgery for complex anal fistula, a common and impactful problem for people with perianal Crohn's disease and cryptoglandular fistulae.
Who Should Pay Attention
Adult patients with perianal/anal fistula (including Crohn's-related fistula), colorectal surgeons, gastroenterologists managing perianal disease, and clinical researchers in IBD/perianal surgery.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment116 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a randomized, open-label trial that will compare Plenvu bowel preparation the evening before surgery versus no bowel preparation.
All participants receive the same oral antibiotics before surgery and then undergo one of three standard sphincter-preserving operations (LIFT, autologous platelet-rich fibrin [Obsidian], or endorectal advancement flap) chosen by the surgeon prior to randomization.
Clinical healing is assessed at 6 months, with clinical exam and a 12-month 3D endoanal ultrasound follow-up. The study is planned for 116 adults and is currently listed as not yet recruiting.
Because participants and surgeons are not blinded and healing assessments are done by the surgical team, interpretation of results will need to consider potential assessment bias.
Keep In Mind
Structured content depth: trial-record. The registry entry describes study design, interventions, planned outcomes, and follow-up but does not report results. The trial is open-label and healing assessment is not blinded, which may affect outcome assessment.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorRegion Skane
Trial IDNCT07897539
Study typeInterventional
Trial phaseNA
Enrollment116 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 27, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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