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

Last updated: December 12, 2023
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Handsewn anastomosis

stapled side-to-side anastomosis

Clinical Study ID

NCT05578235
2022.0533
NL81981.018.22
  • Ages > 16
  • All Genders

Study 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 Criteria

Inclusion

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 tocomply with protocol.
  • Competent and able to provide written informed consent.
  • Patient must have been discussed in the local MDT

Exclusion

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 otherconditions that would, in the opinion of the investigators, compromise the safety ofthe 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 andendoscopy.

Study Design

Total Participants: 165
Treatment Group(s): 2
Primary Treatment: Handsewn anastomosis
Phase:
Study Start date:
July 13, 2023
Estimated Completion Date:
October 01, 2027

Study 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.

Connect with a study center

  • Flevoziekenhuis

    Almere, Flevoland 1315 RA
    Netherlands

    Active - Recruiting

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