Recurrent Crohn's disease
Conditions
Interventions
Intervention (if applicable):Group 1: New procedure for CD, central mesenterectomy when performing ileocolic resection.Group 2: Standard procedure for CD, mesenteric sparing ileocolic resection.
Sponsors
Amsterdam UMC
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: Males and females aged > 16 yearsIleo(colic) disease with an indication for primary ileoceacal or ileocolic resectionAll ocncurrent therapies are permittedAll 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 MDTAbility to comply with protocolCompetent and able to provide written informed consent
Exclusion criteria
Exclusion criteria: Inability to give informed consentPatients less than 16 years of agePatients undergoing repeated ileocolic resectionClinically significant medical conditions within the six months before the operation: e.g. myocardial infarction, active angina, congestive heart failure or other condiitions that would, in the opinion of the investigators, compromise the safety of the patient.History of cancer <5 years which might influence patients prognosisEmergent operationPregnant or beast feedingInability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopyKono S
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the 6 month endoscopic recurrence following a mesenteric sparing (MSI) versus central mesenterectomy (CMI) when performing an ileocolic resection for Crohn's disease | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to determine the 6 months clinical and pathological recurrence, the need for restarting immunosuppressive medication according to protocol within the first year postoperatively, and determine the difference in clinical recurrence at one year postoperatively. Finally, determine the 5 year reoperation rate for recurrence of disease at the anastomotic site. | — |
Countries
Belgium, Italy, Netherlands, United States
Contacts
Public ContactA.E.G. Haanappel
Amsterdam UMC
Outcome results
None listed