Actively Recruiting
Comparing Biologic Treatments to Prevent Crohns Disease Recurrence After Intestinal Surgery
Led by Shanghai 10th People's Hospital · Updated on 2026-07-10
198
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness of different biologic treatments in preventing the return of Crohns disease after surgery. This retrospective study includes 198 adults who had bowel surgery and started biologic therapy between January 2015 and April 2025. The study groups include patients who used anti-TNF biologics like infliximab or adalimumab and those who used non-anti-TNF biologics such as vedolizumab or ustekinumab. The main focus is on the rate of endoscopic recurrence within 6 to 12 months after surgery. The biologic treatments were given as part of routine care and include infliximab, adalimumab, vedolizumab, and ustekinumab with specific dosing schedules. Infliximab and vedolizumab are given intravenously at weeks 0, 2, and 6, followed by maintenance doses every 8 weeks. Adalimumab is administered by injection starting with higher doses at weeks 0 and 2 then every 2 weeks. Ustekinumab starts with a weight-based intravenous dose followed by subcutaneous injections every 8 weeks. Patients are grouped based on the biologic started within six weeks after surgery. Participants medical records will be reviewed to assess outcomes including the rate of endoscopic recurrence, severe recurrence, clinical recurrence over up to 5 years, rehospitalization, reoperation, and drug persistence. The study also examines pathological changes in intestinal tissue and fat and performs subgroup analyses based on recurrence risk and surgery extent. This observational study uses statistical methods to provide real-world data to help guide postoperative biologic treatment choices.
CONDITIONS
Brief Title
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
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