Post-operative Complications and Smoking Habits in Colorectal Surgery
NCT ID: NCT06339671
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1527 participants
OBSERVATIONAL
2024-04-15
2025-09-25
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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NF (Non fumatori)
Non-smoker
No interventions assigned to this group
FT (Fumatori di tobacco)
Tobacco smokers
No interventions assigned to this group
NRT (Nicotine replacement therapy)
Nicotine replacement therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 who have not accepted informed consent.
18 Years
ALL
No
Sponsors
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Ospedale San Paolo
OTHER
Ospedali Riuniti Marche Nord pesaro
UNKNOWN
IRCCS Ospedale San Raffaele
OTHER
Responsible Party
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Pierpaolo Sileri
Professor
Principal Investigators
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Pierpaolo Sileri, Prof.
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Locations
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Prof. Pierpaolo Sileri
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Pierpaolo Sileri
Role: primary
References
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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.
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.
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.
Tsai KY, Huang SH, You JF, Tang R, Chiang JM, Yeh CY, Hsieh PS, Tsai WS, Chiang SF, Lai CC. Smoking cessation for less than 10 years remains a risk factor of anastomotic leakage in mid-to-low rectal cancer patients undergoing sphincter-preserving surgery. Langenbecks Arch Surg. 2022 May;407(3):1131-1138. doi: 10.1007/s00423-021-02381-9. Epub 2022 Jan 26.
Silverstein P. Smoking and wound healing. Am J Med. 1992 Jul 15;93(1A):22S-24S. doi: 10.1016/0002-9343(92)90623-j.
Guerif V, Atlan M, Cristofari S. Pathophysiology of nicotine, place of nicotine substitutes and electronic cigarettes in plastic surgery: A review of the literature. Ann Chir Plast Esthet. 2022 Jun;67(3):119-124. doi: 10.1016/j.anplas.2022.05.001. Epub 2022 Jun 4.
Turan A, Mascha EJ, Roberman D, Turner PL, You J, Kurz A, Sessler DI, Saager L. Smoking and perioperative outcomes. Anesthesiology. 2011 Apr;114(4):837-46. doi: 10.1097/ALN.0b013e318210f560.
Shi Y, Warner DO. Surgery as a teachable moment for smoking cessation. Anesthesiology. 2010 Jan;112(1):102-7. doi: 10.1097/ALN.0b013e3181c61cf9.
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.
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.
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.
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.
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.
Choe SI, Finley C. Confronting the Negative Impact of Cigarette Smoking on Cancer Surgery. Curr Oncol. 2022 Aug 18;29(8):5869-5874. doi: 10.3390/curroncol29080463.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
Related Links
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National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Accessed March 8, 2023
Other Identifiers
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PASSAGE
Identifier Type: -
Identifier Source: org_study_id
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