NCT06339671

Post-operative Complications and Smoking Habits in Colorectal Surgery

Complicanze Post-operatorie e Abitudine Tabagica in Chirurgia Colorettale (Studio PASSAGE). Uno Studio Multicentrico Osservazionale Prospettico e Retrospettivo in Italia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,527 (estimated)
• Sponsor: IRCCS Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Colorectal Disorders

Timeline

• Start date: 2024-04-15
• Primary completion: 2025-09-25
• Completion: 2025-09-25
• First posted: 2024-04-01
• Last updated: 2024-07-24

Locations

1 site across 1 country: Italy