Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
The study is comparing common biologics given after Crohn's surgery to prevent endoscopic recurrence—a key issue for people who have had bowel resection. Knowing which drugs perform better in real‑world practice could affect postoperative treatment choices.
Adult Crohn's patients post‑surgery; gastroenterologists and colorectal surgeons; researchers focused on postoperative recurrence and biologic therapies.
What To Know
This registered observational study (retrospective cohort) compares different biologic drugs started soon after Crohn's surgery to see which best prevents endoscopic recurrence at 6–12 months, a common concern after resection.
The study will include about 198 adults who had intestinal resection and began prophylactic biologic therapy within six weeks after surgery. Patients are grouped as anti‑TNF (infliximab, adalimumab) versus non‑anti‑TNF (vedolizumab, ustekinumab). The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) assessed by ileocolonoscopy at 6–12 months.
Secondary outcomes include severe endoscopic and clinical recurrence, rehospitalization, reoperation, drug persistence, and pathological changes. The study uses retrospective real‑world data and plans multivariable regression and survival analyses; it does not assign treatments.
Results, if published, would inform choice of postoperative biologic therapy but will reflect observational design limitations. Adults with Crohn's disease who have had intestinal resection, gastroenterologists and surgeons managing postoperative care, and researchers studying postoperative recurrence and biologic effectiveness.
This is a retrospective, observational study (recruiting/registry record) and cannot prove causation like a randomized trial. Outcomes depend on availability and quality of postoperative endoscopic and clinical data; subgroup analyses may be underpowered. The registry record summarizes planned analyses, not study results.
This is a retrospective cohort using routine clinical data, so findings will be subject to confounding and selection biases. The registry describes planned methods and outcomes but does not report results.