Back to resultsOutcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection
Primary Purpose
Lung Cancer, Lung Diseases, Lung Cancer, Nonsmall Cell
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Chest Xray
No daily chest xray
Sponsored by
About this trial
This is an interventional other trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult males or females who plan to receive VATS pulmonary resections confined to lobectomies, segmentectomies and wedge resections.
- Willingness to adhere to randomized treatment.
- Ability to answer self- and interviewer- administered questions in English
- Understand and sign a written informed consent form in English
Exclusion Criteria:
- Previous thoracic surgery history in the same side.
- Exploration, biopsy, lung volume reduction surgeries (LVRS), bilobectomies, sleeve resections or pneumonectomies performed.
Sites / Locations
- Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Daily Chest Xray (standard)
Chest Xray post chest tube removal only
Arm Description
Outcomes
Primary Outcome Measures
Number of total chest xrays performed per subject
number of scheduled and additional chest xrays, and how does this correlate with post operative safety
Secondary Outcome Measures
Full Information
NCT ID
NCT03704870
First Posted
February 28, 2018
Last Updated
April 29, 2020
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03704870
Brief Title
Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection
Official Title
A Randomized Controlled Feasibility Study Looking at Differences in Hospital Stay Variables Following Omission of Daily Routine Chest Radiographs After Pulmonary Resection.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Currently, it is the standard of care practice to perform daily routine CXR when a chest tube is in situ following pulmonary resection. However, previous research as well as experience of thoracic surgeons suggested this kind of management has poor diagnostic and therapeutic value. Eliminating daily routine CXR for adult patients having undergone pulmonary surgery might decrease the frequency of radiation exposure and hospitalization costs per patient without increasing reintervention rates, length of hospital stays, readmission rates or any adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Diseases, Lung Cancer, Nonsmall Cell, Surgery, Lung Adenocarcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily Chest Xray (standard)
Arm Type
Active Comparator
Arm Title
Chest Xray post chest tube removal only
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Chest Xray
Intervention Description
Daily chest xray
Intervention Type
Diagnostic Test
Intervention Name(s)
No daily chest xray
Intervention Description
Chest xray will be done post chest tube removal only
Primary Outcome Measure Information:
Title
Number of total chest xrays performed per subject
Description
number of scheduled and additional chest xrays, and how does this correlate with post operative safety
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult males or females who plan to receive VATS pulmonary resections confined to lobectomies, segmentectomies and wedge resections.
Willingness to adhere to randomized treatment.
Ability to answer self- and interviewer- administered questions in English
Understand and sign a written informed consent form in English
Exclusion Criteria:
Previous thoracic surgery history in the same side.
Exploration, biopsy, lung volume reduction surgeries (LVRS), bilobectomies, sleeve resections or pneumonectomies performed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Darling, MD
Organizational Affiliation
UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection
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