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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704870
Other study ID # 17-5398
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 26, 2018
Est. completion date March 31, 2020

Study information

Verified date May 2019
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Chest Xray
Daily chest xray
No daily chest xray
Chest xray will be done post chest tube removal only

Locations

Country Name City State
Canada Toronto General Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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