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Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
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.
Official title: Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy: a Randomized, Multicentre, Parallel Group Pragmatic Non-inferiority Trial in Crohn Disease
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
292
Start Date
2022-09-08
Completion Date
2030-10
Last Updated
2024-12-11
Healthy Volunteers
No
Conditions
Interventions
Biological Drug
Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence
Locations (28)
GZA
Antwerp, Antwerpen, Belgium
UZA
Edegem, Antwerpen, Belgium
Erasmus ziekenhuis
Brussels, Brussels Capital, Belgium
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, Belgium
UZ Brussel
Jette, Brussels Capital, Belgium
CHwapi
Tournai, Henegouwen, Belgium
ZOL Genk
Genk, Limburg, Belgium
CHC Montlégia
Liège, Liège, Belgium
CHU de Liège
Liège, Liège, Belgium
CHU UCL Namur site Godinne
Yvoir, Namur, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Sint lucas Brugge
Bruges, West-Vlaanderen, Belgium
AZ Damiaan
Ostend, West-Vlaanderen, Belgium
OLV Aalst
Aalst, Belgium
Imeldaziekenhuis
Bonheiden, Belgium
AZ Klina
Brasschaat, Belgium
AZ Sint-Jan
Bruges, Belgium
AZ Sint Lucas
Ghent, Belgium
Jessa ziekenhuis
Hasselt, Belgium
AZ Sint Maarten
Mechelen, Belgium
AZ Delta
Roeselare, Belgium
Vitaz
Sint-Niklaas, Belgium
Humanitas research hospital
Milan, Rozzano MI, Italy
IRCCS De Bellis Castellana Grotte
Castellana Grotte, Italy
Careggi University Hospital
Florence, Italy
IRCCS San Raffael Hospital
Milan, Italy