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| Name | Class |
|---|---|
| Ospedale San Paolo | OTHER |
| Ospedali Riuniti Marche Nord pesaro | UNKNOWN |
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PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NF (Non fumatori) | Non-smoker | ||
| FT (Fumatori di tobacco) | Tobacco smokers | ||
| NRT (Nicotine replacement therapy) | Nicotine replacement therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone colorectal surgery. Patients who need to undergo colorectal surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierpaolo Sileri, Prof. | Contact | 0226439091 | livolsi.emanuela@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Pierpaolo Sileri, Prof. | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Pierpaolo Sileri | Recruiting | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28688645 | Background | Gaskill CE, Kling CE, Varghese TK Jr, Veenstra DL, Thirlby RC, Flum DR, Alfonso-Cristancho R. Financial benefit of a smoking cessation program prior to elective colorectal surgery. J Surg Res. 2017 Jul;215:183-189. doi: 10.1016/j.jss.2017.03.067. Epub 2017 Apr 7. | |
| 23799418 | Background | Gronkjaer M, Eliasen M, Skov-Ettrup LS, Tolstrup JS, Christiansen AH, Mikkelsen SS, Becker U, Flensborg-Madsen T. Preoperative smoking status and postoperative complications: a systematic review and meta-analysis. Ann Surg. 2014 Jan;259(1):52-71. doi: 10.1097/SLA.0b013e3182911913. |
| Label | URL |
|---|---|
| National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Accessed March 8, 2023 | View source |
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| 36527323 | Background | Balla A, Saraceno F, Rullo M, Morales-Conde S, Targarona Soler EM, Di Saverio S, Guerrieri M, Lepiane P, Di Lorenzo N, Adamina M, Alarcon I, Arezzo A, Bollo Rodriguez J, Boni L, Biondo S, Carrano FM, Chand M, Jenkins JT, Davies J, Delgado Rivilla S, Delrio P, Elmore U, Espin-Basany E, Fichera A, Flor Lorente B, Francis N, Gomez Ruiz M, Hahnloser D, Licardie E, Martinez C, Ortenzi M, Panis Y, Pastor Idoate C, Paganini AM, Pera M, Perinotti R, Popowich DA, Rockall T, Rosati R, Sartori A, Scoglio D, Shalaby M, Simo Fernandez V, Smart NJ, Spinelli A, Sylla P, Tanis PJ, Valdes-Hernandez J, Wexner SD, Sileri P. Protective ileostomy creation after anterior resection of the rectum: Shared decision-making or still subjective? Colorectal Dis. 2023 Apr;25(4):647-659. doi: 10.1111/codi.16454. Epub 2022 Dec 28. |
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| 19996946 | Background | Shi Y, Warner DO. Surgery as a teachable moment for smoking cessation. Anesthesiology. 2010 Jan;112(1):102-7. doi: 10.1097/ALN.0b013e3181c61cf9. |
| 27474844 | Background | Parthasarathy M, Greensmith M, Bowers D, Groot-Wassink T. Risk factors for anastomotic leakage after colorectal resection: a retrospective analysis of 17 518 patients. Colorectal Dis. 2017 Mar;19(3):288-298. doi: 10.1111/codi.13476. |
| 28766076 | Background | Zhang W, Lou Z, Liu Q, Meng R, Gong H, Hao L, Liu P, Sun G, Ma J, Zhang W. Multicenter analysis of risk factors for anastomotic leakage after middle and low rectal cancer resection without diverting stoma: a retrospective study of 319 consecutive patients. Int J Colorectal Dis. 2017 Oct;32(10):1431-1437. doi: 10.1007/s00384-017-2875-8. Epub 2017 Aug 2. |
| 28166548 | Background | Shahab L, Goniewicz ML, Blount BC, Brown J, McNeill A, Alwis KU, Feng J, Wang L, West R. Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study. Ann Intern Med. 2017 Mar 21;166(6):390-400. doi: 10.7326/M16-1107. Epub 2017 Feb 7. |
| 34432013 | Background | Sun R, Mendez D, Warner KE. Trends in Nicotine Product Use Among US Adolescents, 1999-2020. JAMA Netw Open. 2021 Aug 2;4(8):e2118788. doi: 10.1001/jamanetworkopen.2021.18788. |
| 18313558 | Background | von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008. |
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