Condition: Crohn Disease · Sponsor: Universitaire Ziekenhuizen KU Leuven
With this prospective, randomized, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstrate the non-inferiority of an endoscopy-driven approach, this patient-tailored management could be advocated, while a more expensive systematic introduction of biological therapies could be limited. Finally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.
This description comes directly from the study's public registry record.
Marc Ferrante, Professor · 016 342845 · marc.ferrante@uzleuven.be
Dorien Beeckmans, PhD · 016 348545 · dorien.beeckmans@uzleuven.be
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| ZAS | Antwerp, Antwerpen, Belgium | Recruiting |
| UZA | Edegem, Antwerpen, Belgium | Recruiting |
| Erasmus ziekenhuis | Brussels, Brussels Capital, Belgium | Recruiting |
| Cliniques Universitaires Saint Luc | Brussels, Brussels Capital, Belgium | Recruiting |
| UZ Brussel | Jette, Brussels Capital, Belgium | Recruiting |
| CHwapi | Tournai, Henegouwen, Belgium | Recruiting |
| ZOL Genk | Genk, Limburg, Belgium | Recruiting |
| CHC Montlégia | Liège, Liège, Belgium | Recruiting |
| CHU de Liège | Liège, Liège, Belgium | Recruiting |
| CHU UCL Namur site Godinne | Yvoir, Namur, Belgium | Not Yet Recruiting |
| AZ Maria Middelares | Ghent, Oost-Vlaanderen, Belgium | Recruiting |
| UZ Gent | Ghent, Oost-Vlaanderen, Belgium | Recruiting |
+ 16 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05169593