Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic
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
| Condition(s) | Crohn Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. Fi |
| Who can participate | Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology 3. Males and females 18-80 years old. 4. Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 and 40 days prior to the Screening visit. Patients who underwent an ileocolonic resection with ileocolonic anastomosis with a temporary ileostomy are also eligible if the ileocolonic resection was performed within eight months prior to the Screening visit, and the restoration of the faecal stream was performed within 3 and 40 days prior to the Screening visit. 5. Pati |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Locations | Antwerp, Antwerpen, Belgium; Edegem, Antwerpen, Belgium; Brussels, Brussels Capital, Belgium; Brussels, Brussels Capital, Belgium; Jette, Brussels Capital, Belgium; Tournai, Henegouwen, Belgium (+22 more sites) |
| Start date | 2022-09-08 |
| NCT ID | NCT05169593 |
| Official listing | https://clinicaltrials.gov/study/NCT05169593 |