Prof. Pierpaolo Sileri
Milan, Italy
Location status: Recruiting
Location contact
Pierpaolo Sileri
CONTACT
NCT Number: NCT06339671
PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milan, Italy
Location status: Recruiting
Pierpaolo Sileri
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: 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).
Contact information is provided by the study sponsor or research team.
IRCCS Ospedale San Raffaele
Other
Complicanze Post-operatorie e Abitudine Tabagica in Chirurgia Colorettale (Studio PASSAGE). Uno Studio Multicentrico Osservazionale Prospettico e Retrospettivo in Italia
Acronym: PASSAGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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