Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339671
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-25
Brief Title:
Post-operative Complications and Smoking Habits in Colorectal Surgery
Sponsor:
IRCCS Ospedale San Raffaele
Organization:
IRCCS Ospedale San Raffaele
Study Overview
Official Title:
Complicanze Post-operatorie e Abitudine Tabagica in Chirurgia Colorettale Studio PASSAGE Uno Studio Multicentrico Osservazionale Prospettico e Retrospettivo in Italia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASSAGE
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None