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RECRUITING
NCT05169593
PHASE4

Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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

DRUG

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