Clinical trial NCT06734780: Effects of Vaping on Post-operative Recurrence of Crohn's Disease
Official title: Effects of Vaping on Post-operative Recurrence of Crohn's Disease: a Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After Resection
Keywords: Crohn
e-cigarette
smoke
tobacco
heat-not-burn tobacco
postoperative recurrence
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (age ≥18) patients with an established diagnosis of Crohn's disease who underwent surgical resections of a tract of intestine accessible through endoscopy.

Brief 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.

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

Primary outcomes:
measure: Endoscopic recurrence e-cigarettes vs no-smoke
timeFrame: Endoscopic recurrence will assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.
Secondary outcomes:
measure: Endoscopic recurrence e-cigarettes vs tobacco
timeFrame: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.
measure: Endoscopic recurrence tobacco vs no-smoke
timeFrame: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.
measure: Endoscopic recurrence heat-not-burn tobacco vs tobacco
timeFrame: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.
measure: Risk of recurrence
timeFrame: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
state: Michigan
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Tommaso Lo Parigi, MD
role: PRINCIPAL_INVESTIGATOR
References: