Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease
Not applicable · Testing stapled side-to-side anastomosis and Handsewn anastomosis · 1 site · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing stapled side-to-side anastomosis (a procedure) and Handsewn anastomosis (a procedure) as a possible treatment. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 16 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 3 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 165 participants are expected to take part.
- Start date: 2023-07-13.
- Main results expected around 2027-10-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Netherlands.
Main thing being measured
- Postoperative endoscopic recurrence at 6 months (6 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Collaborators | ZonMw: The Netherlands Organisation for Health Research and Development |
| Enrollment | 165 (estimated) |
| Start date | 2023-07-13 |
| Primary completion (est.) | 2027-10-01 |
| First posted | 2022-10-13 |
| Last updated | 2023-12-18 |
| 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) |
| ClinicalTrials.gov ID | NCT05578235 |
Interventions
- stapled side-to-side anastomosis (Procedure)
Standard procedure for CD - Handsewn anastomosis (Procedure)
handsewn end-to-end or Kono-s anastomosis
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Flevoziekenhuis | Almere Stad, Flevoland | Netherlands | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.