Perspectives of Receiving Open Versus Minimally Invasive Surgery

NCT01807390 | Unknown

• 1 other identifier: 20120321-01H
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the perspectives of patients' undergoing surgery for lung or esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions regarding pain and surgical complications. This study will also assess a general health related quality of life pre-op and post-op. Additionally, it will examine the importance of receiving care close to home and their support system. Hypotheses:

1. 1.The data will allow investigators to better understand the willingness of patients to participate in prospective, randomized studies comparing minimally invasive and open thoracic surgery. Patients will not be willing to undergo randomization to an open versus minimally invasive surgical procedure.
2. 2.The pain associated with Minimally Invasive Surgery (MIS) will be perceived and documented as lesser than open surgery.
3. 3.Patients may be willing to accept a higher risk of complications or more post-operative pain if they were given the option to be cared for closer to their home.

Conditions

Lung Cancer; Esophageal Cancer

Keywords

Minimally invasive surgery; Patient perspectives; Lung cancer; Esophageal cancer; Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain perceptions

  Patients will rate their perceptions of pain associated with surgery both pre-op and at 4 weeks and 6 months post-op.

  Baseline, 4 weeks and 6 months

Secondary Outcomes (1)

• Change in general health related quality of life

  Baseline, 4 weeks and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the Ottawa Hospital General Campus who are surgical candidates for lung or esophageal cancer over the age of 18.

You may qualify if:

• Patients who are surgical candidates for lung or esophageal cancer (entered at pre-op time point)

You may not qualify if:

• Below 18 years of age.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms; Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastien Gilbert, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 8, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CA (1)