Actively Recruiting
Effects of Vaping on Post-operative Recurrence of Crohn's Disease
Led by IRCCS Ospedale San Raffaele · Updated on 2024-12-16
600
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Vaping on Post-operative Recurrence of Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older with an established diagnosis of Crohn's disease
- Patients who underwent surgical resection of an intestinal segment accessible by endoscopy
- Patients who had ileo-colic resections due to Crohn's disease or its complications, regardless of the type of anastomosis
- Patients with clearly documented smoking status (smoking tobacco, vaping, or nonsmoking) in medical records
- Data collected from January 2000 to August 2024
You will not qualify if you...
- Patients who had surgeries other than intestinal resections (e.g., stricturoplasty, dilation, bypass)
- Patients who had intestinal resections for reasons other than Crohn's disease, such as cancer or trauma
- Patients without endoscopic reassessment of the anastomosis within 12 months after surgery
- Patients with unconfirmed Crohn's disease diagnosis
- Patients with unknown smoking habits
- Patients with mixed smoking habits, such as smoking both tobacco and e-cigarettes simultaneously or changing smoking type after surgery and before endoscopic reassessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele
Milan, Michigan, Italy, 20132
Actively Recruiting
Research Team
T
Tommaso Lo Parigi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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