Effects of Vaping on Post-operative Recurrence of Crohn's Disease (VAPE-CD)

Effects of Vaping on Post-operative Recurrence of Crohn's Disease: a Retrospective Multicenter Study

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.

Study Overview

• Status: Recruiting
• Conditions: The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After Resection

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Tommaso Lo Parigi, MD; Phone Number: +39-022643275 02 2643 2756; Email: parigi.tommaso@hsr.it

Study Locations

• Italy
  • Michigan
    • Milano, Michigan, Italy, 20132
      • Recruiting
      • IRCCS San Raffaele
      • Contact: Tommaso Lo Parigi, MD; Phone Number: +39-022643275 0226432756; Email: parigi.tommaso@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adult patients (age ≥18) diagnosed with CD; Patients who underwent intestinal resections due to Crohn's disease or its complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: IRCCS Ospedale San Raffaele
• Investigators: Principal Investigator: Tommaso Lo Parigi, MD, Irccs Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: tobacco; e-cigarette; Crohn; smoke; postoperative recurrence; heat-not-burn tobacco
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Recurrence; Crohn Disease
• Other Study ID Numbers: VAPE-CD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No