Prediction of Postoperative Recurrence in Crohn's Disease

Crohn's disease is characterized by chronic relapsing intestinal inflammation, and a substantial proportion of patients eventually require intestinal resection because of complications such as strictures, penetrating disease, or failure of medical therapy. Postoperative recurrence remains common, but reliable biomarkers and validated prediction models for identifying patients at high risk of recurrence are still lacking.

This is a multicenter, prospective, observational cohort study designed to investigate the predictors and molecular mechanisms of postoperative recurrence in Crohn's disease. The study consists of a screening cohort and a validation cohort. Approximately 200 patients with Crohn's disease undergoing intestinal resection will be enrolled, including 100 participants in the screening cohort and 100 participants in the validation cohort. In addition, approximately 50 patients undergoing intestinal resection for colorectal tumors, diverticular disease, or other non-inflammatory bowel disease conditions will be enrolled as controls.

In the screening cohort, residual surgical specimens that would otherwise be discarded will be collected. Clinical characteristics, follow-up information, biological samples, and multi-omics data will also be collected. Molecular profiling will include analyses such as bulk transcriptomics, single-cell transcriptomics, spatial transcriptomics, proteomics, microbiome analysis, and metabolomics, as applicable. Differences between patients with and without postoperative recurrence will be evaluated, and machine-learning methods will be used to construct a multimodal prediction model.

The validation cohort will be used to evaluate the predictive performance of the multimodal model in a multicenter setting. Postoperative recurrence will be assessed using clinical, endoscopic, and imaging evaluations during follow-up. The study also aims to investigate molecular pathways associated with postoperative recurrence and to identify potential therapeutic targets.

This study is observational. No randomized assignment or protocol-mandated treatment will be provided. Clinical management and postoperative treatment decisions will be made independently by the treating physicians according to routine clinical practice.

Inclusion criteria

• Crohn's Disease Cohorts:

• Diagnosis of Crohn's disease according to the diagnostic criteria of the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).
• Patients with Crohn's disease who require surgical resection of the diseased intestinal segment because of complications such as stricturing or penetrating disease, or because of failure of medical therapy.

Non-IBD Control Cohort:

1.Patients who require surgical resection of an intestinal segment because of conditions such as colorectal tumors or diverticular disease.

Exclusion criteria

• Crohn's Disease Cohorts:

• Uncertain diagnosis of Crohn's disease.
• Clinical history or medical records are substantially incomplete, making it impossible to determine the time of recurrence or whether postoperative recurrence occurred.

Non-IBD Control Cohort:

• Coexisting inflammatory bowel disease or other rheumatic or autoimmune diseases.
• Substantially incomplete clinical history or medical records.