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Fast Tracking in VATS Lobectomy: A Prospective, Historically Controlled, Propensity-Matched Clinical Trial

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ClinicalTrials.gov Identifier: NCT02584322
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Other: Enhanced Recovery pathway Not Applicable

Detailed Description:

Lung cancer is the most common cause of cancer related death in men and women worldwide annually. In North America in 2009, an estimated 246,000 people were diagnosed with lung cancer, and 178,000 died as a result. Lobectomy consists of the surgical removal of an anatomic lobe of the lung. It represents the standard of care in the treatment of malignant lesions involving one lobe of the lung. This operation can be performed either with a chest incision with rib spreading (thoracotomy) or with a minimally invasive approach which does not include rib spreading (thoracoscopy - Video Assisted Thoracoscopic Surgery; VATS).

In the last decade, the trend towards implementation of protocols to enhance patient recovery and diminish length of stay has been gaining popularity and increasing in prevalence. Those protocols are commonly referred to as fast track surgery or enhanced recovery after surgery protocol. The rationale behind these protocols is that by combining multimodal therapies that reduce surgical stress, having good pain control post-operatively, and involving the patient in this process, the treating team has the potential to reduce length of stay.

In the last few years, many surgeons in their respective centers have implemented the use of fast track surgery in the thoracic surgery service. It has been shown to be a safe and effective method for managing postoperative patients after lobectomy. Fast track surgery is a systemic approach to the management of surgical patients, where all the different actions to take postoperatively are standardized and reproducible. Fast track surgery has the potential to diminish the rate of postoperative complications, the length of stay, and achieve a similar patient recovery. In an era, where medical costs are on the rise, hospital beds are limited and nursing staff not always available, fast track surgery has the potential to improve increase throughput, improve efficiency, decrease costs and improve surgical productivity.

Currently, at the CHUM - Notre-Dame Hospital, there is no standardized patient care pathway for patients 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 Enhanced Recovery Program (ERP) will permit a reproducible and routine management for patients following their surgery.

The principal outcomes that will be compared amongst patients pre and post implementation of this protocol will be the length of stay and the number of complications. The investigators think that the results will be different between these two groups. The rational for this is due to the fact that the patients in this Enhanced Recovery Program will have: (1) their urinary catheter removed sooner, (2) their thoracic drain removed earlier and (3) they will be mobilized more quickly. These differences will enable these patients to potentially have less complications post operatively and decrease their hospital stay.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fast Tracking in VATS Lobectomy: A Prospective, Historically Controlled, Propensity-Matched Clinical Trial
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ERAS patients
Enhanced recovery pathway
Other: Enhanced Recovery pathway
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).




Primary Outcome Measures :
  1. Comprehensive Complication Index [ Time Frame: 30 days post operative ]
    Number and Severity of Complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing a VATS lobectomy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584322


Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
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Principal Investigator: Moishe Liberman, MD, PhD Centre Hospitalier Universitaire de Montreal
Publications:

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02584322    
Other Study ID Numbers: 14.386
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017