- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03824977
Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery (PREOTEST)
February 18, 2022 updated by: University Hospital, Rouen
The objective of this study is to evaluate the performances of the Six-Minute Stepper Test (6MST) and Sit To Stand test (STST) to predict post-operative complications after minimally invasive lung cancer resection.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
122
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rouen, France
- Boujibar , F
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consecutive patients are included.
On the day of the surgical consultation, the patient is informed of the modalities of the study by the thoracic surgeon and collects his non-opposition of participation.
He is also evaluated by a physiotherapist, who supervises the realization of 6MST and STST.
Description
Inclusion Criteria:
- Age >18
- Non-small cell lung cancer stage I to II, justifying major resection by VATS or RATS (segmentectomy, lobectomy, pneumonectomy), with or without histological confirmation
Exclusion Criteria:
- Partial or total amputation localized to the lower limb;
- Weight greater than 100 kg;
- Orthopedic, vascular or neurological disorders leading to the incapacity of realize the 6MST;
- Patient under tutorship or curatorship;
- Pregnant woman.
- Surgery canceled
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
occurrence of a post-operative complication grade ≥ 2 on the Clavien-Dindo scale within three months after surgery
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2018
Primary Completion (Actual)
February 4, 2020
Study Completion (Actual)
February 4, 2020
Study Registration Dates
First Submitted
January 29, 2019
First Submitted That Met QC Criteria
January 29, 2019
First Posted (Actual)
January 31, 2019
Study Record Updates
Last Update Posted (Actual)
March 7, 2022
Last Update Submitted That Met QC Criteria
February 18, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A02694-51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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