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

NCT05578235 | Recruiting

• 2 other identifiers: 2022.0533NL81981.018.22
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

Crohn's disease; Ileocolic; Endoscopic Recurrence; Ileocolic Anastomosis

Outcome Measures

Primary Outcomes (1)

• Postoperative endoscopic recurrence at 6 months

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

  6 months

Secondary Outcomes (6)

• Post-operative 30 days complications

  30 days after surgery

• Histologic and clinical recurrence rate at 6 months following ileocolic resection

  6 months after surgery

• Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence

  1 year after surgery

• The 5 year reoperation rate for recurrence of disease at the anastomotic site.

  5 year

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  1 year after surgery

Study Arms (2)

stapled side-to-side anastomosis

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

* 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

Interventions

stapled side-to-side anastomosis PROCEDURE

Standard procedure for CD

stapled side-to-side anastomosis

Handsewn anastomosis PROCEDURE

handsewn end-to-end or Kono-s anastomosis

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Flevoziekenhuis

Almere Stad, Flevoland, 1315 RA, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 38408943 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• W.A. Bemelman, Prof. dr.

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anouck EG Haanappel, MD

CONTACT

0031650828323; a.e.g.haanappel@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 13, 2022
• Study Start: July 13, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)