Effects of Vaping on Post-operative Recurrence of Crohn's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Ospedale San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 1 trial groupGroup A: Adult patients (age ≥18) diagnosed with CD
Trial outcomes
Primary outcomes
1
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.
Time frame
Endoscopic recurrence will assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.Secondary outcomes
1
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.
Time frame
Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.2
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.
Time frame
Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.3
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.
Time frame
Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.4
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
Time frame
Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov