Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease (END2END)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Crohn Disease

Treatments: Procedure: Handsewn anastomosis; Procedure: stapled side-to-side anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05578235

NL81981.018.22 (Other Identifier)

2022.0533

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 2 patient groups

stapled side-to-side anastomosis

Active Comparator group

Description:

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

Treatment:

Procedure: stapled side-to-side anastomosis

Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis

Active Comparator group

Description:

* 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

Treatment:

Procedure: Handsewn anastomosis