Optimising surgical anastomosis in ileocolic resection for Crohn's disease to reduce recurrent disease: A Randomized controlled trial comparing hand-sewn (END-TO-END or Kono-S) to stapled anastomosis (END2END study)

Recruiting

Conditions: Recurrent Crohn's disease
return of Crohn's disease
10017969
10017998

Registration Number: NL-OMON56161

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 165

Inclusion Criteria

1. Males and females aged >16 years
2. Ileocolic disease or disease of the neoterminal ileum with an indication for
resection
3. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX,
antibiotics, and anti-TNF therapy are permitted.
4. All patients should have ileocolic disease or disease of the neoterminal
ileum previously confirmed during endoscopy, with a recent update of imaging
(e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))
5. Ability to comply with protocol.
6. Competent and able to provide written informed consent.
7. Patiënt must have been discussed in the local MDT

Exclusion Criteria

1. Inability to give informed consent.
2. patients less than 16 years of age.
3. 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.
4. History of cancer < 5 years which might influence patients prognosis
5. Emergent operation.
6. Pregnant or breast feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Endoscopic recurrence at six months following ileocolic resection defined as<br /><br>SES-CD of the terminal ileum >2 and Rutgeerts >i2b by central reading.<br /><br><br /><br><br /><br>Primary Objective: Recurrence at six months following ileocolic resection<br /><br>defined as Rutgeerts<br /><br>>i2b assessed by local and central reading separately for comparison blinded<br /><br>for the type of anastomoses. The quality of endoscopic scoring and over scoring<br /><br>will be assessed comparing local scoring by the treating gastroenterologist and<br /><br>the central reading scoring for the different types of anastomoses.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br>• Post-operative 30 days complications<br /><br>• Histologic and clinical recurrence at 6 months<br /><br>• Clinical recurrence within 1 year<br /><br>• Need for restarting immunosuppressive medication within the first year<br /><br>postoperatively for endoscopic or clinical recurrence.<br /><br>• QOL as measured by EuroQol, IBDQ and SF-36 at baseline and at 6 months<br /><br>• Health care consumption and costs of readmission, outpatient clinic and<br /><br>diagnostics<br /><br>• The 5 year reoperation rate for recurrence of disease at the anastomotic<br /><br>site.</p><br>