Flevoziekenhuis
Almere Stad, Flevoland, 1315 RA, Netherlands
Location status: Recruiting
Location contact
Jarmila van der Bilt, dr.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05578235
The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.
Interested in participating?
Request Info16 year and older
All sexes
Interventional
Not applicable
Almere Stad, Flevoland, 1315 RA, Netherlands
Location status: Recruiting
Jarmila van der Bilt, dr.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard procedure for CD
handsewn end-to-end or Kono-s anastomosis
Time frame: 6 months
The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts > i2b by central reading
Time frame: 30 days after surgery
Time frame: 6 months after surgery
Time frame: 1 year after surgery
Time frame: 5 year
Time frame: 1 year after surgery
Quality of life measured with IBD questionnaire
Time frame: 1 year after surgery
Hospital costs per patients in each group
Contact information is provided by the study sponsor or research team.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
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)
Acronym: END2END
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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