RecruitingNot Applicable

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

China198 participantsStarted 2026-01-16

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy. * Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy. * No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment. * Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Endoscopic recurrence rate

Timeframe: 6 to 12 months after surgery

Trial details

NCT IDNCT07694674

SponsorShanghai 10th People's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Inflamatory Bowel Disease trials