RECRUITINGINTERVENTIONAL
Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease
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 Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
- Patient must have been discussed in the local MDT
Who Should NOT Join This Trial:
- Inability to give willing to sign a consent form.
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
PROCEDURE
stapled side-to-side anastomosis
Standard procedure for CD
PROCEDURE
Handsewn anastomosis
handsewn end-to-end or Kono-s anastomosis
Locations (1)
Flevoziekenhuis
Almere Stad, Flevoland, Netherlands