The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After ResectionVAPE-CDNCT06734780
Effects of Vaping on Post-operative Recurrence of Crohn's Disease
An observational study of The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After Resection, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After Resection
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, Michigan, 20132
Tommaso Lo Parigi, MD, 0226432756 ext. +39-022643275, parigi.tommaso@hsr.it
About this study
Official title: 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.
Read the 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.
- Keywords
- Crohn, e-cigarette, smoke, tobacco, heat-not-burn tobacco, postoperative recurrence
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients (age ≥18) diagnosed with CD | Patients who underwent intestinal resections due to Crohn's disease or its complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Endoscopic recurrence will assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Endoscopic recurrence assessed within the first 12 months after an intestinal surgical resection for active or complicated Crohn's disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start30 Nov 2024
- Primary completion30 Mar 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Lorenzo Parigi, IRCCS Ospedale San Raffaele
- Investigators
- Tommaso Lo Parigi, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734780
- Sponsor's protocol ID
- VAPE-CD
- Acronym
- VAPE-CD
- Status last verified
- Aug 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vaping on Post-operative Recurrence of Crohn's Disease: a Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06734780
- Acronym / sponsor ID
- VAPE-CD / VAPE-CD
- Keywords
- Crohn, e-cigarette, smoke, tobacco, heat-not-burn tobacco, postoperative recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients (age ≥18) diagnosed with CD | – | –Patients who underwent intestinal resections due to Crohn's disease or its complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
4 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommaso Lo Parigi, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After Resection, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Lo Parigi, MD (02 2643 2756 ext. +39-022643275, parigi.tommaso@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.