Impact of Smoking on Post-operative Complications in Colorectal Surgery
Complicanze Post-operatorie e Abitudine Tabagica in Chirurgia Colorettale (Studio PASSAGE). Uno Studio Multicentrico Osservazionale Prospettico e Retrospettivo in Italia
IRCCS Ospedale San Raffaele · NCT06339671
This study looks at how smoking affects recovery and complications after colorectal surgery in patients who smoke, use nicotine replacement, or don’t smoke at all.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1527 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06339671 on ClinicalTrials.gov |
What this trial studies
This observational study examines the relationship between smoking habits and post-operative complications in patients undergoing colorectal surgery. It involves a national multicenter cohort of patients, divided into three groups: tobacco smokers, those using nicotine replacement therapy, and non-smokers. The first phase collects retrospective data over six months, while the second phase is prospective and lasts one year, allowing for a comprehensive analysis of complications across different smoking statuses. The study aims to determine if smoking significantly influences post-operative outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older undergoing elective or emergency colorectal surgery in Italy, regardless of their smoking status.
Not a fit: Patients under 18 years old or those who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved post-operative care and tailored interventions for colorectal surgery patients based on their smoking habits.
How similar studies have performed: Previous studies have indicated that smoking can adversely affect surgical outcomes, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years old. * Patients who have read, understood, accepted and signed the informed consent to the study. * Patients with benign or malignant colorectal disease. * Patients undergoing colorectal surgery with any type of approach (open or minimally invasive) in Italy. * Patients undergoing elective and emergency colorectal surgery. * Patients NF (non smoker), FT (tobacco smokers), NRT (nicotine replacement therapy). Are considered smokers that patients who have smoked for at least 30 days at the time of surgery Exclusion Criteria: * Patients \< 18 years old. * Patients who have not accepted informed consent.
Where this trial is running
Milan
- Prof. Pierpaolo Sileri — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Pierpaolo Sileri, Prof. — IRCCS Ospedale San Raffaele
- Study coordinator: Pierpaolo Sileri, Prof.
- Email: livolsi.emanuela@hsr.it
- Phone: 0226439091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Disorders