Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection
A Randomized Controlled Feasibility Study Looking at Differences in Hospital Stay Variables Following Omission of Daily Routine Chest Radiographs After Pulmonary Resection.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lung-cancer
Started Jan 2018
Shorter than P25 for phase_2 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2018
CompletedFirst Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedMay 1, 2020
May 1, 2019
1.9 years
February 28, 2018
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of total chest xrays performed per subject
number of scheduled and additional chest xrays, and how does this correlate with post operative safety
30 days
Study Arms (2)
Daily Chest Xray (standard)
ACTIVE COMPARATORChest Xray post chest tube removal only
EXPERIMENTALInterventions
Chest xray will be done post chest tube removal only
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous thoracic surgery history in the same side.
- Exploration, biopsy, lung volume reduction surgeries (LVRS), bilobectomies, sleeve resections or pneumonectomies performed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail Darling, MD
UHN
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2018
First Posted
October 15, 2018
Study Start
January 26, 2018
Primary Completion
December 31, 2019
Study Completion
March 31, 2020
Last Updated
May 1, 2020
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share