Impact of Vaping on Recurrence of Crohn's Disease After Surgery
Effects of Vaping on Post-operative Recurrence of Crohn's Disease: a Retrospective Multicenter Study
This study is trying to see how vaping and different types of tobacco smoke affect the chances of Crohn's disease coming back after surgery in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan, Michigan) |
| Trial ID | NCT06734780 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how vaping affects the post-operative recurrence of Crohn's disease in patients who have undergone surgical resections. It will compare the effects of e-cigarette smoke, heat-not-burn tobacco products, and traditional tobacco smoke on disease recurrence. The study will also account for various known risk factors that may influence outcomes, such as biologic treatment and the nature of surgical resections. Data will be collected from patients aged 18 and older with a confirmed diagnosis of Crohn's disease from January 2000 to August 2024.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with Crohn's disease who have undergone surgical resections of the intestine.
Not a fit: Patients who have not undergone intestinal resections or have Crohn's disease complications unrelated to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the risks associated with vaping for Crohn's disease patients, potentially guiding treatment decisions.
How similar studies have performed: There are currently no studies evaluating the impact of e-cigarette smoke on post-operative recurrence of Crohn's disease, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age ≥18) patients with an established diagnosis of Crohn's disease.- Patients who underwent surgical resections of a tract of intestine accessible through endoscopy. * Patients who underwent ileo-colic resections due to Crohn's disease or its complications (stricture or fistula) irrespective of the type of anastomosis (side-to-side L-L, , end-to-end T-T, end-to-side T-L, Kono S, iso or antiperistaltic) * Patients whose smoking habit (or nonsmoking habit) is clearly reported in the medical records * Data will be collected from January 2000 to August 2024. Exclusion Criteria: * Patients who underwent surgical operations different from intestinal resections (i.e. stricturoplasty raffias, dilation, bypass etc) * Patients who underwent Intestinal resections for indications other than Crohn's disease (inflammatory, stricturing or fistulizing) such as: cancer, trauma, etc * Patients who for any reason did not undergo endoscopic reassessment of the anastomosis within 12 months from surgery * Unconfirmed diagnosis of Crohn's disease * Patients whose smoking habits could not be determined * Patients with mixed smoking habits, defined as smoking at the same time tobacco cigarettes and e-cigarettes or who have changed type of smoking product (from tobacco to vaping or vice versa) after the intestinal resection and before the endoscopic reassessment
Where this trial is running
Milan, Michigan
- IRCCS San Raffaele — Milan, Michigan, Italy (Recruiting)
Study contacts
- Principal investigator: Tommaso Lo Parigi, MD — IRCCS Ospedale San Raffaele
- Study coordinator: Tommaso Lo Parigi, MD
- Email: parigi.tommaso@hsr.it
- Phone: 02 2643 2756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.