Crohn Disease
Conditions
Keywords
Crohn's disease, Ileocolic, Endoscopic Recurrence, Ileocolic Anastomosis
Brief summary
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.
Detailed description
Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.
Interventions
PROCEDUREstapled side-to-side anastomosis
Standard procedure for CD
PROCEDUREHandsewn anastomosis
handsewn end-to-end or Kono-s anastomosis
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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
Randomised controlled trial. Patients with Crohn's disease will be randomised in a 1:2 ratio for stapled side-to-side anastomose versus handsewn anastomosis (either end-to-end or Kono-S) when performing an ileocolic resection for Crohn's disease.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative endoscopic recurrence at 6 months | 6 months | The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts \> i2b by central reading |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histologic and clinical recurrence rate at 6 months following ileocolic resection | 6 months after surgery | — |
| Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence | 1 year after surgery | * Endoscopic recurrence defined as Rutgeerts \> i2b * Clinical recurrence difned as recurrent CD-related symptoms |
| Post-operative 30 days complications | 30 days after surgery | — |
| Inflammatory Bowel Disease Questionnaire (IBDQ) | 1 year after surgery | Quality of life measured with IBD questionnaire |
| Hospital costs | 1 year after surgery | Hospital costs per patients in each group |
| The 5 year reoperation rate for recurrence of disease at the anastomotic site. | 5 year | — |
Countries
Netherlands
Contacts
Primary ContactAnouck EG Haanappel, MD
Outcome results
None listed