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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584322
• Other study ID #: 14.386
• Status: Completed
• Phase: N/A
• First received: October 21, 2015
• Last updated: August 31, 2017
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing a VATS lobectomy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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).

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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

Cerfolio RJ, Pickens A, Bass C, Katholi C. Fast-tracking pulmonary resections. J Thorac Cardiovasc Surg. 2001 Aug;122(2):318-24. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):133-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehensive Complication Index	Number and Severity of Complications	30 days post operative