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Recruiting

NCT Number: NCT06339671

Post-operative Complications and Smoking Habits in Colorectal Surgery

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Pierpaolo Sileri

Milan, Italy

Location status: Recruiting

Location contact

Pierpaolo Sileri

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence and severity of postoperative complications surgery in three groups

    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).

Secondary outcomes

  1. Incidence and severity of postoperative complications surgery in NF (non-smokers) group

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Pierpaolo Sileri, Prof.

CONTACT

[email protected]

0226439091

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Collaborators

  • Ospedale San Paolo
  • Ospedali Riuniti Marche Nord pesaro

Registry information

Official study title

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

Acronym: PASSAGE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
Jul 24, 2024

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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