NCT02584322

Brief Summary

Currently, at the CHUM - Notre-Dame Hospital, there is no standardized patient care pathway for patients undergoing Video Assisted Thoracic Surgery (VATS) lobectomy. The investigators goal is to implement an Enhanced Recovery Program (ERP) for patient undergoing VATS lobectomy. The care given to patient prior to the implementation of this protocol was different amongst patients and depended on the surgeon's preferences. The implementation of this ERP will permit a reproducible and routine management for patients following their surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

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

October 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

October 21, 2015

Last Update Submit

August 31, 2017

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Comprehensive Complication Index

    Number and Severity of Complications

    30 days post operative

Study Arms (1)

ERAS patients

EXPERIMENTAL

Enhanced recovery pathway

Other: Enhanced Recovery pathway

Interventions

Enhanced Recovery pathwayOTHER

The enhanced recovery pathway consists of postoperative medical orders including nursing care, investigations and tests, and other peri-operative orders. The enhanced recovery pathway is standardized for all patients, and can be discontinued at any time when clinical judgment mandates (i.e. patient has a severe complication).

ERAS patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing a VATS lobectomy

You may not qualify if:

  • Less than 18 year old, inability to consent, VATS lobectomy conversion to open lobectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (8)

  • Howington JA, Gunnarsson CL, Maddaus MA, McKenna RJ, Meyers BF, Miller D, Moore M, Rizzo JA, Swanson S. In-hospital clinical and economic consequences of pulmonary wedge resections for cancer using video-assisted thoracoscopic techniques vs traditional open resections: a retrospective database analysis. Chest. 2012 Feb;141(2):429-435. doi: 10.1378/chest.10-3013. Epub 2011 Jul 21.

    PMID: 21778260BACKGROUND

  • Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7.

    PMID: 20610543BACKGROUND

  • Carrott PW Jr, Jones DR. Teaching video-assisted thoracic surgery (VATS) lobectomy. J Thorac Dis. 2013 Aug;5 Suppl 3(Suppl 3):S207-11. doi: 10.3978/j.issn.2072-1439.2013.07.31.

    PMID: 24040525BACKGROUND

  • Flores RM, Park BJ, Dycoco J, Aronova A, Hirth Y, Rizk NP, Bains M, Downey RJ, Rusch VW. Lobectomy by video-assisted thoracic surgery (VATS) versus thoracotomy for lung cancer. J Thorac Cardiovasc Surg. 2009 Jul;138(1):11-8. doi: 10.1016/j.jtcvs.2009.03.030.

    PMID: 19577048BACKGROUND

  • McKenna RJ Jr, Mahtabifard A, Pickens A, Kusuanco D, Fuller CB. Fast-tracking after video-assisted thoracoscopic surgery lobectomy, segmentectomy, and pneumonectomy. Ann Thorac Surg. 2007 Nov;84(5):1663-7; discussion 1667-8. doi: 10.1016/j.athoracsur.2007.05.058.

    PMID: 17954081BACKGROUND

  • Zehr KJ, Dawson PB, Yang SC, Heitmiller RF. Standardized clinical care pathways for major thoracic cases reduce hospital costs. Ann Thorac Surg. 1998 Sep;66(3):914-9. doi: 10.1016/s0003-4975(98)00662-6.

    PMID: 9768951BACKGROUND

  • Cerfolio RJ, Pickens A, Bass C, Katholi C. Fast-tracking pulmonary resections. J Thorac Cardiovasc Surg. 2001 Aug;122(2):318-24. doi: 10.1067/mtc.2001.114352.

    PMID: 11479505BACKGROUND

  • Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.

    PMID: 23728278BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Moishe Liberman, MD, PhD

    Centre Hospitalier Universitaire de Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 22, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

August 1, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

CA(1)