Post-operative Complications and Smoking Habits in Colorectal Surgery

ConditionColorectal Disorders

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIRCCS Ospedale San Raffaele

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients < 18 years old.

Patients who have not accepted informed consent.

Trial population

Patients who have undergone colorectal surgery. Patients who need to undergo colorectal surgery.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,527 Participants

are grouped into 3 trial groups

Group A: NF (Non fumatori)

Group B: FT (Fumatori di tobacco)

Group C: NRT (Nicotine replacement therapy)

Trial outcomes

Primary outcomes

Incidence and severity of postoperative complications surgery in three groups

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

Secondary outcomes

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

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).

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Ospedale San Raffaele

Lead sponsor

Ospedale San Paolo

Collaborator

Ospedali Riuniti Marche Nord pesaro