NCT06339671

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,527

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

March 25, 2024

Last Update Submit

July 23, 2024

Conditions

Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    30 days

Study Arms (3)

NF (Non fumatori)

Non-smoker

FT (Fumatori di tobacco)

Tobacco smokers

NRT (Nicotine replacement therapy)

Nicotine replacement therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients \< 18 years old.
  • Patients who have not accepted informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Pierpaolo Sileri

Milan, Italy

RECRUITING

Related Publications (17)

  • 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.

    PMID: 28688645BACKGROUND

  • 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.

    PMID: 23799418BACKGROUND

  • 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.

    PMID: 36527323BACKGROUND

  • 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.

    PMID: 35079889BACKGROUND

  • Silverstein P. Smoking and wound healing. Am J Med. 1992 Jul 15;93(1A):22S-24S. doi: 10.1016/0002-9343(92)90623-j.

    PMID: 1323208BACKGROUND

  • 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.

    PMID: 35672174BACKGROUND

  • 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.

    PMID: 21372682BACKGROUND

  • Shi Y, Warner DO. Surgery as a teachable moment for smoking cessation. Anesthesiology. 2010 Jan;112(1):102-7. doi: 10.1097/ALN.0b013e3181c61cf9.

    PMID: 19996946BACKGROUND

  • 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.

    PMID: 27474844BACKGROUND

  • 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.

    PMID: 28766076BACKGROUND

  • 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.

    PMID: 28166548BACKGROUND

  • 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.

    PMID: 34432013BACKGROUND

  • 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.

    PMID: 18313558BACKGROUND

  • 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.

    PMID: 36005201BACKGROUND

  • 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.

    PMID: 3558716BACKGROUND

  • 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.

    PMID: 19638912BACKGROUND

  • 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.

    PMID: 20004450BACKGROUND

Related Links

Study Officials

  • Pierpaolo Sileri, Prof.

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierpaolo Sileri, Prof.

CONTACT

0226439091livolsi.emanuela@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

April 15, 2024

Primary Completion

September 25, 2025

Study Completion

September 25, 2025

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations

IT(1)