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Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY

This retrospective cohort study aims to compare the efficacy of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD). It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025. Patients will be divided into anti-TNF (e.g., infliximab, adalimumab) and non-anti-TNF (e.g., vedolizumab, ustekinumab) groups based on the biologic started within 6 weeks post-surgery. The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively. Secondary outcomes include severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and histopathological changes in the bowel and mesenteric fat. Subgroup analyses will explore treatment effects by recurrence risk stratification and resection extent. Using retrospective data collection, the study will apply multivariate regression and survival analysis to provide real-world evidence for optimizing postoperative biologic selection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
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• Age ≥18 years.

• Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings.

• Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection.

• Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery.

• Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months.

• Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence.

Locations
Other Locations
China
The Tenth People's Hospital of Shanghai
RECRUITING
Shanghai
Time Frame
Start Date: 2026-01-16
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 198
Treatments
Postoperative anti-TNF biologics group
Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic anti-TNF biologic therapy within 6 weeks after surgery, including infliximab or adalimumab. All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.
Postoperative non-anti-TNF biologics group
Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic non-anti-TNF biologic therapy within 6 weeks after surgery, including vedolizumab or ustekinumab. All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.
Related Therapeutic Areas
Sponsors
Leads: Shanghai 10th People's Hospital

This content was sourced from clinicaltrials.gov