Comparing biologic medicines for stopping Crohn's disease from returning after bowel surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who had bowel surgery and started a biologic medicine within 6 weeks afterwards. Past records are reviewed.

Age

18 to 85 years

Sex

All sexes can join.

Disease stage

Crohn's disease with a bowel resection (ileocolonic, small bowel or colon) related to the disease.

Earlier treatment

Must have started a biologic medicine within 6 weeks after surgery and kept taking it for at least 3 to 6 months.

Biomarker or test result

A check of the bowel with a camera (ileocolonoscopy) 6 to 12 months after surgery for the Rutgeerts score, or other data to judge a return of symptoms.

Main reasons for not taking part

• Other bowel diseases such as intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis or bowel cancer
• Bowel surgery done mainly for reasons other than IBD, such as cancer
• No usable check of the bowel 6 to 12 months after surgery and not enough other data
• Irregular use of the medicine after surgery because of severe illness or serious infection
• Other conditions the investigators think make joining inappropriate

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 85 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• 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.

  Treatment: Infliximab and Adalimumab

• 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.

  Treatment: Vedolizumab and Ustekinumab (UST)