The objective of this study is to evaluate if in the prevention of postoperative recurrence of ileal Crohn's disease immediate initiation of azathioprine postoperatively is superior to delayed (6- 12 mths.) introduction of azathioprine upon disease recurrence assessed by endoscopic criteria. The primary endpoint, disease recurrence, encompasses symptomatic and surgical recurrence as well as severe endoscopic lesions at the final, 2 year, assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
63
See arm/group descriptions
See arm/group descriptions
See arm/group descriptions
See arm/group descriptions
Imelda Ziekenhuis
Bonheiden, Belgium
UZ Leuven
Leuven, Belgium
Univerzity Karlovy
Prague, Czechia
Evangelismos Hospital
Athens, Greece
Endoscopic remission
The proportion of patients with endoscopic remission (Rutgeerts' postoperative endoscopic score i0 or i1) at 102 weeks
Time frame: Week 102
Complete endoscopic remission
The percentage of patients with a Rutgeerts' score of i0 at 102 weeks
Time frame: Week 102
Absence of endoscopic relapse
The percentage of patients with a Rutgeerts' score of i0-i2 at 102 weeks
Time frame: Week 102
Clinical remission
The percentage of patients in clinical remission (Crohn's disease activity index, CDAI \<150) at 102 weeks
Time frame: Week 102
Sustained clinical remission
Crohn's disease activity index, CDAI \< 150 throughout the 102 weeks study period
Time frame: Week 102
Radiological remission
The percentage of patients with radiological remission at 102 weeks.
Time frame: Week 102
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