Crohn's Disease
Conditions
Keywords
Crohn's Disease, Ileocolic, Mesenteric Sparing, Extended Mesenterectomy
Brief summary
The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.
Detailed description
There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery rather than just of the bowel alone. A more extensive central mesenterectomy (up to the level of the ileocolic artery), in order to remove an increased volume of affected mesentery to prevent postoperative CD, has been suggested to lead to beneficial results. It is hypothesised that patients who undergo a central mesenterectomy during an ileocolic resection compared to a mesenteric sparing ileocolic resection will have decreased recurrence rates.
Interventions
Mesentery left in situ
PROCEDURECentral mesenterectomy ileocolic resection
Mesentery is taken up to the level of the ileocolic trunk
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
Intervention model description
Patients with Crohn's disease will be randomised in a 1:1 ratio for mesenteric sparing versus central mesenterectomy when performing an ileocolic resection for Crohn's disease
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Ileocolic disease with an indication for ileocecal resection 2. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted. 3. 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. 4. Ability to comply with protocol. 5. Competent and able to provide written informed consent. 6. Patient must have been discussed in the local MDT
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection | 6 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity | 30 days after surgery | Number of patients with Postoperative morbidity |
| Clinical recurrence rate following ileocolic resection | 1 year after surgery | Number of patients with Clinical recurrence rate following ileocolic resection |
| The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence | 1 year after surgery | .The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence |
| The 5 year reoperation rate for recurrence of disease at the anastomotic site. | 5 years | The 5 year reoperation rate for recurrence of disease at the anastomotic site. |
Countries
Netherlands
Outcome results
None listed