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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.
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 :
The subjects considered are adult patients (≥18 years) diagnosed with CD who underwent surgical resections of a tract of intestine accessible through endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients (age ≥18) diagnosed with CD | Patients who underwent intestinal resections due to Crohn's disease or its complications |
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| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic recurrence e-cigarettes vs no-smoke | Rate of endoscopic recurrence (defined as a Rutgeerts score ≥ i2) in patients who smoke e-cigarettes in the first year after intestinal resection for active Crohn's disease compared to the endoscopic recurrence rate in patients who do not smoke. | Endoscopic recurrence will assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic recurrence e-cigarettes vs tobacco | The rate of endoscopic recurrence (defined as a Rutgeerts score ≥i2) in patients who smoke e-cigarettes in the first year after an intestinal resection for active Crohn's disease compared to the endoscopic recurrence rate in patients who smoke tobacco cigarettes. | Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult (age ≥18) patients with an established diagnosis of Crohn's disease who underwent surgical resections of a tract of intestine accessible through endoscopy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tommaso Lo Parigi, MD | Contact | 02 2643 2756 | +39-022643275 | parigi.tommaso@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Tommaso Lo Parigi, MD | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Recruiting | Milan | Michigan | 20132 | Italy |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| Endoscopic recurrence tobacco vs no-smoke | The rate of endoscopic recurrence (defined as a Rutgeerts score ≥i2) in patients who smoke tobacco cigarettes in the first year after an intestinal resection for active Crohn's disease compared to the endoscopic recurrence rate in patients who do not smoke. | 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 | The rate of endoscopic recurrence (defined as a Rutgeerts score ≥i2) in patients who smoke heat-not-burn tobacco products in the first year after an intestinal resection for active Crohn's disease compared to the endoscopic recurrence rate in patients who smoke tobacco cigarettes. | Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease. |
| Risk of recurrence | Odds ratio of endoscopic recurrence between e-cigarettes and non-smokers calculated with a multivariable logistic regression analysis including the following variables: biologic prophylactic treatment, intestinal resections prior to index surgery, penetrating complications | Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease. |