Post-operative Complications and Smoking Habits in Colorectal Surgery

Recruiting

• Conditions: Colorectal Disorders

• Registration Number: NCT06339671
• Lead Sponsor: IRCCS Ospedale San Raffaele

Brief Summary

PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled.

Detailed Description

The first part of the study is retrospective and data collection will be done the first 6 months. The enrolled patients will be divided into three groups (FT: tobacco smokers; NRT: nicotine replacement therapy; NF: non-smokers) and the data will be compared between groups to evaluate whether there are statistically significant differences regarding postoperative complications. The NF group will also be divided into patients who have never smoked and patients who have stopped smoking. A further analysis of ex-smoking patients will be performed to evaluate whether the incidence of complications differs from that observed in patients who have never smoked. The second part of the study will be prospective and will last one year. Also in this study the enrolled patients will be divided into three groups (NF group, FT group, and NRT group) and data obtained from all recorded variables will be compared between the groups. The data obtained retrospectively and prospectively will be analyzed together for each group.

The hypothesis of the study is that tobacco smoking plays a significant role in the appearance of postoperative complications. In particular, it is hypothesized that the group of patients taking NRT (defined as the group of NRT patients) has a higher incidence of postoperative complications after colorectal surgery than that observed in the control group of non-smoking (NF) or ex-smoking patients and lower to the group of tobacco smoking patients (FT).

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Study Start: 2024-04-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-09-25
• Study Completion: 2025-09-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1527

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of postoperative complications surgery in three groups	30 days	Incidence of postoperative complications (new onset) within 30 days from the date of surgery in the three groups of patients (NF, FT, NRT).

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of postoperative complications surgery in NF (non-smokers) group	30 days	Incidence of postoperative complications (new onset) within 30 days from the date of surgery in the two groups of NF patients (patients who have never smoked and patients who have stopped smoking).

Trial Locations

Locations (1)

Prof. Pierpaolo Sileri; 🇮🇹 Milan, Italy