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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06339671

Acronym

PASSAGE

Enrollment

1527

Registered

2024-04-01

Start date

2024-04-15

Completion date

2025-09-25

Last updated

2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disorders

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Italy

Contacts

Primary ContactPierpaolo Sileri, Prof.

livolsi.emanuela@hsr.it0226439091

Outcome results