Recurrent Crohn's disease
Conditions
Interventions
The following groups will be compared:
Group 1 (intervention): Handsewn end to end anastomosis (end to end or Kono-s)
Group 2 (standard): Stapled side to side anastomosis
Sponsors
Amsterdam UMC
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Endoscopic recurrence at six months following ileocolic resection defined as SES-CD of the terminal ileum >2 and Rutgeerts >i2b by central reading. Primary Objective: Recurrence at six months following ileocolic resection defined as Rutgeerts >i2b assessed by local and central reading separately for comparison blinded for the type of anastomoses. The quality of endoscopic scoring and over scoring will be assessed comparing local scoring by the treating gastroenterologist and the central reading scoring for the different types of anastomoses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: • Post-operative 30 days complications • Histologic and clinical recurrence at 6 months • Clinical recurrence within 1 year • Need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence. • QOL as measured by EuroQol, IBDQ and SF-36 at baseline and at 6 months • Health care consumption and costs of readmission, outpatient clinic and diagnostics • The 5 year reoperation rate for recurrence of disease at the anastomotic site. | — |
Countries
Netherlands
Contacts
Public ContactO. Bakar
Amsterdam UMC
Outcome results
None listed