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

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ClinicalTrials.gov Identifier: NCT05578235
Recruitment Status : Recruiting
First Posted : October 13, 2022
Last Update Posted : December 18, 2023
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Willem A. Bemelman, Amsterdam UMC, location AMC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Procedure: stapled side-to-side anastomosis Procedure: Handsewn anastomosis Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial. Patients with Crohn's disease will be randomised in a 1:2 ratio for stapled side-to-side anastomose versus handsewn anastomosis (either end-to-end or Kono-S) when performing an ileocolic resection for Crohn's disease.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: There is no blinding to the treatment allocation for the treating surgeon. The treatment will be blinded for the treating gastroenterologist, the endoscopist and the participants.
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 13, 2023
Estimated Primary Completion Date : October 1, 2027
Estimated Study Completion Date : October 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
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
 Procedure: stapled side-to-side anastomosis
Standard procedure for CD
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
 Procedure: Handsewn anastomosis
handsewn end-to-end or Kono-s anastomosis


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative endoscopic recurrence at 6 months [ Time Frame: 6 months ]
    The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts > i2b by central reading


Secondary Outcome Measures :
  1. Post-operative 30 days complications [ Time Frame: 30 days after surgery ]
  2. Histologic and clinical recurrence rate at 6 months following ileocolic resection [ Time Frame: 6 months after surgery ]
  3. Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence [ Time Frame: 1 year after surgery ]
    • Endoscopic recurrence defined as Rutgeerts > i2b
    • Clinical recurrence difned as recurrent CD-related symptoms

  4. The 5 year reoperation rate for recurrence of disease at the anastomotic site. [ Time Frame: 5 year ]
  5. Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 1 year after surgery ]
    Quality of life measured with IBD questionnaire

  6. Hospital costs [ Time Frame: 1 year after surgery ]
    Hospital costs per patients in each group


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05578235


Contacts
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Contact: Anouck EG Haanappel, MD 0031650828323 a.e.g.haanappel@amsterdamumc.nl

Locations
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Netherlands
Flevoziekenhuis Recruiting
Almere, Flevoland, Netherlands, 1315 RA
Principal Investigator: Jarmila van der Bilt, dr.         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: W.A. Bemelman, Prof. dr. Amsterdam UMC, location AMC
More Information
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Responsible Party: Willem A. Bemelman, Prof. dr., Amsterdam UMC, location AMC
ClinicalTrials.gov Identifier: NCT05578235    
Other Study ID Numbers: 2022.0533
NL81981.018.22 ( Other Identifier: CCMO )
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Willem A. Bemelman, Amsterdam UMC, location AMC:
Crohn's disease
Ileocolic
Endoscopic Recurrence
Ileocolic Anastomosis
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases