Financial benefit of a smoking cessation program prior to elective colorectal surgery.
Cameron E Gaskill, Catherine E Kling, Thomas K Varghese...
https://pubmed.ncbi.nlm.nih.gov/28688645Actively Recruiting
Age: 18Years +
All Genders
ID06339671
Post-operative Complications and Smoking Habits in Colorectal Surgery A Multicenter Observational Study in Italy
Led by IRCCS Ospedale San Raffaele · Updated on 2024-07-24
1527
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
IRCCS Ospedale San Raffaele
Lead Sponsor
O
Ospedale San Paolo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting PASSAGE, a national multicenter observational study in Italy, to understand how smoking habits affect post-operative complications in patients undergoing colorectal surgery. This study includes both retrospective data collection over six months and prospective data collection lasting one year. The goal is to compare outcomes among three groups: tobacco smokers, patients using nicotine replacement therapy, and non-smokers, including those who have never smoked and those who have quit. Participants will be grouped into smokers, nicotine replacement therapy users, and non-smokers. Data from both retrospective and prospective study phases will be combined to analyze differences in the incidence and severity of complications after surgery. The study specifically investigates whether nicotine replacement therapy patients experience more complications than non-smokers but fewer than active smokers. During the study, researchers will collect detailed information about each patient's surgery and smoking status, tracking complications within 30 days after the procedure. The study involves both elective and emergency colorectal surgeries using any surgical approach. Patient consent and health data will be handled with care, and the total participation duration varies depending on which phase the patient is enrolled in.
CONDITIONS
Brief Title
Post-operative Complications and Smoking Habits in Colorectal Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years old or older
- Patients who have read, understood, and signed informed consent
- Patients with benign or malignant colorectal disease
- Patients undergoing colorectal surgery by any approach in Italy
- Patients undergoing elective or emergency colorectal surgery
- Patients who are non-smokers, tobacco smokers, or using nicotine replacement therapy (smokers defined as having smoked for at least 30 days before surgery)
You will not qualify if you...
- Patients under 18 years old
- Patients who have not signed informed consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Post-operative Follow-up
Duration - 30 days
Participants are observed for postoperative complications and smoking habits are monitored after colorectal surgery.
Approximately 1 visit within 30 days after surgery
Long-term Monitoring
Duration - 1 year
Participants are monitored prospectively for one year to collect data on postoperative complications and smoking status.
Periodic assessments during the 1-year follow-up
Trial Site Locations
Total: 1 location
1
Prof. Pierpaolo Sileri
Milan, Italy
Actively Recruiting
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Research Team
P
Pierpaolo Sileri, Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Alparslan Turan, Edward J Mascha, Dmitry Roberman...
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Yu Shi, David O Warner
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M Parthasarathy, M Greensmith, D Bowers...
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Wei Zhang, Zheng Lou, Qizhi Liu...
https://pubmed.ncbi.nlm.nih.gov/28766076