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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Flevoziekenhuis
RECRUITING
Almere Stad
Contact Information
Primary
Anouck EG Haanappel, MD
a.e.g.haanappel@amsterdamumc.nl
0031650828323
Time Frame
Start Date: 2023-07-13
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 165
Treatments
Active_comparator: stapled side-to-side anastomosis
Standard procedure for CD, ileocolic resection with side-to-side anastomosis is done according to local practice with a linear stapler either aniso- or isoperistaltic as advised by the ECCO guidelines
Active_comparator: Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis
* Kono-S (anti-mesenteric functionel end-to-end handsewn) anastomosis is done according to the description by Kono~* End-to-end handsewen anastomosis is fashioned either by enlarging the small bowel diameter by an antimesenteric incision to fit the large bowel lumen or by tailored resection of a part of the staple line of the cross stapled colon
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov

Similar Clinical Trials