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

Sponsor

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

Overall Status

Not yet recruiting

CT.gov ID

NCT05578235

Collaborator

(none)

189

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Procedure: stapled side-to-side anastomosis Procedure: Handsewn anastomosis	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

189 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.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)

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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

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

Primary Outcome Measures

Postoperative endoscopic recurrence at 6 months [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 [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]
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. [5 year]
Inflammatory Bowel Disease Questionnaire (IBDQ) [1 year after surgery]
Quality of life measured with IBD questionnaire
Hospital costs [1 year after surgery]
Hospital costs per patients in each group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: W.A. Bemelman, Prof. dr., Amsterdam UMC, location AMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Willem A. Bemelman, Prof. dr., Amsterdam UMC, location AMC

ClinicalTrials.gov Identifier:

NCT05578235

Other Study ID Numbers:

2022.0533
NL81981.018.22

First Posted:

Oct 13, 2022

Last Update Posted:

Oct 13, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Willem A. Bemelman, Prof. dr., Amsterdam UMC, location AMC

Crohn's disease

Ileocolic

Endoscopic Recurrence

Ileocolic Anastomosis

Additional relevant MeSH terms:

Crohn Disease

Study Results

No Results Posted as of Oct 13, 2022