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

NCT ID: NCT05578235

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2027-10-01

Brief Summary

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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

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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.

Conditions

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Crohn Disease

Keywords

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Crohn's disease Ileocolic Endoscopic Recurrence Ileocolic Anastomosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

stapled side-to-side anastomosis

Intervention Type PROCEDURE

Standard procedure for CD

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

Group Type ACTIVE_COMPARATOR

Handsewn anastomosis

Intervention Type PROCEDURE

handsewn end-to-end or Kono-s anastomosis

Interventions

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stapled side-to-side anastomosis

Standard procedure for CD

Intervention Type PROCEDURE

Handsewn anastomosis

handsewn end-to-end or Kono-s anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Willem A. Bemelman

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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W.A. Bemelman, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location AMC

Locations

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Flevoziekenhuis

Almere Stad, Flevoland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Anouck EG Haanappel, MD

Role: CONTACT

Phone: 0031650828323

Email: [email protected]

References

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Haanappel AEG, Bellato V, Buskens CJ, Armuzzi A, van der Bilt JDW, de Boer NKH, Danese S, van der Does de Willebois EML, Duijvestein M, van der Horst D, Pellino G, Richir MC, Selvaggi F, Spinelli A, Vignali A, Rosati R, Bemelman WA. Optimising surgical anastomosis in ileocolic resection for Crohn's disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES). BMC Surg. 2024 Feb 26;24(1):71. doi: 10.1186/s12893-024-02340-3.

Reference Type DERIVED
PMID: 38408943 (View on PubMed)

Other Identifiers

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NL81981.018.22

Identifier Type: OTHER

Identifier Source: secondary_id

2022.0533

Identifier Type: -

Identifier Source: org_study_id