Effects of Vaping on Post-operative Recurrence of Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After Resection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Vaping on Post-operative Recurrence of Crohn's Disease: a Retrospective Multicenter Study
Overview
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.
Primary outcome measures
- Endoscopic recurrence e-cigarettes vs no-smoke [Time frame: Endoscopic recurrence will assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.]
Secondary outcome measures (4)
- Endoscopic recurrence e-cigarettes vs tobacco [Time frame: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.]
- Endoscopic recurrence tobacco vs no-smoke [Time frame: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.]
- Endoscopic recurrence heat-not-burn tobacco vs tobacco [Time frame: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.]
- Risk of recurrence [Time frame: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS San Raffaele — Milan
Identifiers
NCT: NCT06734780 · VAPE-CD