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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Procedure: stapled side-to-side anastomosis; Procedure: Handsewn anastomosis

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 Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anouck EG Haanappel, MD; Phone Number: 0031650828323; Email: a.e.g.haanappel@amsterdamumc.nl

Study Locations

• Netherlands
  • Flevoland
    • Almere, Flevoland, Netherlands, 1315 RA
      • Recruiting
      • Flevoziekenhuis
      • Principal Investigator: Jarmila van der Bilt, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic and clinical recurrence rate at 6 months following ileocolic resection		6 months after surgery
Post-operative 30 days complications		30 days after surgery
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	1 year after surgery
The 5 year reoperation rate for recurrence of disease at the anastomotic site.		5 year
Inflammatory Bowel Disease Questionnaire (IBDQ)	Quality of life measured with IBD questionnaire	1 year after surgery
Hospital costs	Hospital costs per patients in each group	1 year after surgery

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: W.A. Bemelman, Prof. dr., Amsterdam UMC, location AMC

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: October 1, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Crohn's disease; Endoscopic Recurrence; Ileocolic Anastomosis; Ileocolic
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2022.0533; NL81981.018.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No