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

Primary Purpose

Crohn Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stapled side-to-side anastomosis
Handsewn anastomosis
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's disease, Ileocolic, Endoscopic Recurrence, Ileocolic Anastomosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females aged >18 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 MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
  • 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 18 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    stapled side-to-side anastomosis

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

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Postoperative endoscopic recurrence at 6 months
    The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts > i2b by central reading

    Secondary Outcome Measures

    Post-operative 30 days complications
    Histologic and clinical recurrence rate at 6 months following ileocolic resection
    Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
    Endoscopic recurrence defined as Rutgeerts > i2b Clinical recurrence difned as recurrent CD-related symptoms
    The 5 year reoperation rate for recurrence of disease at the anastomotic site.
    Inflammatory Bowel Disease Questionnaire (IBDQ)
    Quality of life measured with IBD questionnaire
    Hospital costs
    Hospital costs per patients in each group

    Full Information

    First Posted
    October 1, 2022
    Last Updated
    October 10, 2022
    Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05578235
    Brief Title
    Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease
    Acronym
    END2END
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn Disease
    Keywords
    Crohn's disease, Ileocolic, Endoscopic Recurrence, Ileocolic Anastomosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    189 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    stapled side-to-side anastomosis
    Arm Type
    Active Comparator
    Arm 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
    Arm Title
    Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis
    Arm Type
    Active Comparator
    Arm 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
    Intervention Type
    Procedure
    Intervention Name(s)
    stapled side-to-side anastomosis
    Intervention Description
    Standard procedure for CD
    Intervention Type
    Procedure
    Intervention Name(s)
    Handsewn anastomosis
    Intervention Description
    handsewn end-to-end or Kono-s anastomosis
    Primary Outcome Measure Information:
    Title
    Postoperative endoscopic recurrence at 6 months
    Description
    The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts > i2b by central reading
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Post-operative 30 days complications
    Time Frame
    30 days after surgery
    Title
    Histologic and clinical recurrence rate at 6 months following ileocolic resection
    Time Frame
    6 months after surgery
    Title
    Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
    Description
    Endoscopic recurrence defined as Rutgeerts > i2b Clinical recurrence difned as recurrent CD-related symptoms
    Time Frame
    1 year after surgery
    Title
    The 5 year reoperation rate for recurrence of disease at the anastomotic site.
    Time Frame
    5 year
    Title
    Inflammatory Bowel Disease Questionnaire (IBDQ)
    Description
    Quality of life measured with IBD questionnaire
    Time Frame
    1 year after surgery
    Title
    Hospital costs
    Description
    Hospital costs per patients in each group
    Time Frame
    1 year after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and females aged >18 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 MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease. 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 18 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anouck EG Haanappel, MD
    Phone
    0031650828323
    Email
    a.e.g.haanappel@amsterdamumc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    W.A. Bemelman, Prof. dr.
    Organizational Affiliation
    Amsterdam UMC, location AMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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