RecruitingRecruiting
Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease
NCT05578235 · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
In plain English
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Official title
Optimising Surgical Anastomosis in Ileocolic Resection for Crohn's Disease to Reduce Recurrent Disease: A Randomised Controlled Trial Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis (END-to-END Study)
About this study
Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.
Eligibility criteria
Inclusion Criteria:
* Males and females aged \>16 years
* Ileocolic disease or disease of the neoterminal ileum with an indication for resection
* Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
* All patients should have undergone a colonoscopy and a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))- Ability to comply with protocol.
* Competent and able to provide written informed consent.
* Patient must have been discussed in the local MDT
Exclusion Criteria:
* Inability to give informed consent.
* Patients less than 16 years of age.
* Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
* History of cancer \< 5 years which might influence patients prognosis
* Emergent operation.
* Pregnant or breast feeding.
* Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
Study design
Enrollment target: 165 participants
Allocation: randomized
Masking: double
Age groups: child, adult, older_adult
Timeline
Starts: 2023-07-13
Estimated completion: 2027-10-01
Last updated: 2023-12-18
Interventions
Procedure: stapled side-to-side anastomosisProcedure: Handsewn anastomosis
Primary outcomes
- • Postoperative endoscopic recurrence at 6 months (6 months)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · other
With: ZonMw: The Netherlands Organisation for Health Research and Development
Contacts & investigators
ContactAnouck EG Haanappel, MD · contact · a.e.g.haanappel@amsterdamumc.nl · 0031650828323
InvestigatorW.A. Bemelman, Prof. dr. · principal_investigator, Amsterdam UMC, location AMC
All locations (1)
FlevoziekenhuisRecruiting
Almere Stad, Flevoland, Netherlands