Engels: recurrent Crohn´s disease located in the terminal ileum, infliximab, ileocolic resection, QALY, Laparoscopy. (NLD: recidiverende ziekte van Crohn in het terminale ileum, infliximab, ileocecaal resectie, QALY, laparoscopie).
Conditions
Interventions
1. Infliximab: remission induction - three subsequent infusions at week 0, 2 and 6 in a dose of 5 mg/kg
maintenance therapy - infusions of 5 mg/kg at 8 to 12 weeks intervals in case of active disease after infliximab remission induction treatment. In case of disease recurrence during infliximab treatmen
2. Laparoscopic ileocolic resection: prior to surgery remission induction consisting of prednisolone 40 mg OD for two weeks, 30 mg OD during two weeks and 25 mg OD for 1 week, followed by a dose 20 mg
Sponsors
Academic Medical Center (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age in between 18 and 80 years; 2. recurrent Crohn's disease of the distal ileum; 3. a stable dose of immunomodulatory therapy for at least 8 weeks; 4. a completed IBDQ and EQ-5D before randomization; 5. informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior ileocolic resection for Crohn's disease; 2. Obstructive Crohn's disease of the distal ileum requiring surgery; 3. diseased small bowel segment longer than 40 cm; 4. abdominal abscesses, fistula's and abdominal fluid collections; 5. ASA III en iV; 6. Co-morbidity requiring infliximab treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Disease-specific quality of life, as measured with the IBDQ; 2. Costs per QALY. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General quality of life, as measured by the SF-36 and EuroQol 5D questionnaires; 2. Number of days on sick leave; 3. Days unable to participate in social life; 4. Morbidity (due to either surgery or medical treatment); 5. Total in and out hospital medical and non-medical costs; 6. Body image and cosmesis as measured by the body image questionnaire. | — |
Contacts
Public ContactE.J. Groof, de
Dept. of Surgery and dept. of Gastroenterology & Hepatology Academic Medical Center
Outcome results
None listed