Clinical trial NCT06339671: Post-operative Complications and Smoking Habits in Colorectal Surgery
Official title: Complicanze Post-operatorie e Abitudine Tabagica in Chirurgia Colorettale (Studio PASSAGE). Uno Studio Multicentrico Osservazionale Prospettico e Retrospettivo in Italia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Disorders
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
Collaborators: name: Ospedale San Paolo
name: Ospedali Riuniti Marche Nord pesaro
First posted: 2024-04-01
Enrollment: 1527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone colorectal surgery. Patients who need to undergo colorectal surgery.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of postoperative complications surgery in three groups
timeFrame: 30 days
Secondary outcomes:
measure: Incidence and severity of postoperative complications surgery in NF (non-smokers) group
timeFrame: 30 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Prof. Pierpaolo Sileri
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Pierpaolo Sileri, Prof.
role: PRINCIPAL_INVESTIGATOR
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