Laparoscopic ileocolic resection versus infliximab treatment of recurrent distal ileitis in Crohn's disease: a randomized multicenter trial

Laparoscopic ileocolic resection versus infliximab treatment of recurrent distal ileitis in Crohn's disease: a randomized multicenter trial - LIR!C

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31330

Enrollment

130

Registered

2007-10-24

Start date

2007-12-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohns disease terminal ileitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - age between 18 and 80 years - recurrent Crohn's disease of the distal ileum - a stable dose of immunomodulatory therapy for at least 8 weeks

Exclusion criteria

Exclusion criteria: - prior ileocolic resection for Crohn's disease - Obstructive Crohn's disease of the distal ileum requiring surgery - diseased small bowel segment longer than 40 cm - abdominal abscesses, fistula's and abdominal fluid collections - ASA III and IV

Design outcomes

Primary

Measure	Time frame
1. Disease-specific quality of life, as measured with the IBDQ(28-32) 2. Costs per QALY	—

Secondary

Measure	Time frame
1. General quality of life, as measured by the SF-36 and EuroQol 5D questionnaires(28-32) 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.	—

Countries

Netherlands

Outcome results