Mesenteric Sparing versus more extended mesenterectomy in Ileocolic Resection for ileocecal Crohn*s Disease

Phase 3

Recruiting

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

Registration Number: NL-OMON53021

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 118

Inclusion Criteria

11) Males and females aged >16 years,
2) Ileo(colic) disease with an indication for primary ileocaecal - or ileocolic
resection,
3) All concurrent therapies are permitted,
4) All patients should have terminal ileitis (L1 or L3 disease), previously
confirmed during endoscopy, with a recent update (<= 3 months) of imaging (e.g.
ultrasound, MR, CT enterography) before confirmation eligibility, preferably
discussed in MDT,
5) ability to comply with protocol,
6) competent and able to provide written informed consent.

Exclusion Criteria

1. Inability to give informed consent.
2. patients less than 16 years of age.
3. Patients undergoing repeated ileocolic resection.
4. 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.
5. History of cancer < 5 years which might influence patients prognosis
6. Emergent operation.
7. Pregnant or breast feeding.
8. Inability to follow up at 3, 6 and 12 months for postoperative assessment,
imaging and endoscopy.
9. Kono S

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Determine the 6 month endoscopic recurrence following a mesenteric sparing<br /><br>(MSI) versus central mesenterectomy (CMI) when performing an ileocolic<br /><br>resection for Crohn*s disease.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to determine the 6 months clinical and<br /><br>pathological recurrence, the need for restarting immunosuppressive medication<br /><br>according to protocol within the first year postoperatively, and determine the<br /><br>difference in clinical recurrence at one year postoperatively. Finally,<br /><br>determine the 5 year reoperation rate for recurrence of disease at the<br /><br>anastomotic site.<br /><br><br /><br></p><br>