Postoperative biologic therapy in Crohn's disease: which agent works best to prevent recurrence after surgery?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective cohort analysis comparing the effectiveness of post-surgical biologic therapies (anti-TNF and non-anti-TNF agents) in adults with Crohn's disease. Patients who had intestinal resection and started a prophylactic biologic within six weeks post-surgery are grouped by whether they received anti-TNF agents (infliximab, adalimumab) or non-anti-TNF agents (vedolizumab, ustekinumab). The primary endpoint is endoscopic recurrence (Rutgeerts score ≥ i2) at 6–12 months, with secondary outcomes including severe recurrence, clinical recurrence, rehospitalization, reoperation, drug persistence, POCER index, and histopathology. Analyses will adjust for recurrence risk and resection extent using multivariate and survival methods to provide real-world evidence for postoperative biologic selection.

Why it matters

Who can join: the full rules

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 evaluate.
* Other conditions considered by the investigators to be inappropriate for inclusion.

Where it's running

• The Tenth People's Hospital of Shanghai
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.