NCT06734780

Effects of Vaping on Post-operative Recurrence of Crohn's Disease

Effects of Vaping on Post-operative Recurrence of Crohn's Disease: a Retrospective Multicenter Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: IRCCS Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tobacco smoke is a well-established risk factor for post-operative recurrence of Crohn's disease. Over the last few decades electronic cigarettes have gained popularity as an alternative to traditional tobacco, however, their effects on Crohn's disease are unknown. Tobacco smoke negatively impacts most outcomes of Crohn's disease including, but not limited to, response to therapy and risk of hospitalization. Smoke is particularly relevant in the post-operative setting, as it increases the chance of disease recurrence after surgical resection, and therefore prophylactic treatment with biologics is recommended in Crohn's patients who smoke. At present, there are no studies evaluating the impact of e-cigarette smoke on post-operative recurrence and therefore informing physicians on the appropriateness of prophylactic treatment in this subset of patients. This study aims to assess the impact of vaping (or smoking of electronic cigarettes) on Crohn's disease endoscopic recurrence after resection as compared to non-smoke and smoke of traditional tobacco cigarettes.

Detailed description

This is a multicenter study with the aim of evaluate the effect of e-cigarette smoke (vaping) on Crohn's disease post-operative. Secondary objectives are : * To evaluate the effect of e-cigarette smoke on Crohn's disease postoperative recurrence compared to tobacco smoke. * To determine the effect of heat-not-burn tobacco products (ie. IQOS) on Crohn's disease postoperative recurrence compared to tobacco smoke. * To determine the effect of tobacco smoke on Crohn's disease postoperative recurrence compared to nonsmokers. * To account for the confounding effect of known risk factors of post- operative recurrence: biologic treatment for postoperative prophylaxis, penetrating complications, multiple intestinal resections. The subjects considered are adult patients (≥18 years) diagnosed with CD who underwent surgical resections of a tract of intestine accessible through endoscopy.

Conditions

• The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After Resection

Timeline

• Start date: 2024-11-30
• Primary completion: 2025-03-30
• Completion: 2025-08-01
• First posted: 2024-12-16
• Last updated: 2024-12-16

Locations

1 site across 1 country: Italy