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Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery (PREOTEST)

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ClinicalTrials.gov Identifier: NCT03824977
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date January 29, 2019
First Posted Date January 31, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date November 21, 2018
Actual Primary Completion Date November 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2019)
occurrence of a post-operative complication grade ≥ 2 on the Clavien-Dindo scale within three months after surgery [ Time Frame: 30 minutes ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03824977 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery
Official Title Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery
Brief Summary The purpose of this study is to determine the predictive interest of the 6-minute stepper test in preoperative thoracic surgery. The goal is through this test to determine the risk of postoperative complications.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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. It is also evaluated by a physiotherapist, who supervises the realization of 6MST and STST.
Condition To Evaluate the Predictive Performance of the 6-minute Stepper Test on the Risk of Complications
Intervention Diagnostic Test: Six minutes stepper test
The patient carries out the two tests before surgery then we observe the occurrence of postoperative complications
Other Name: sit to stand test
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 29, 2019)
106
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 20, 2020
Actual Primary Completion Date November 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age >18
  • Non-small cell lung cancer stage I to II, justifying resection major pulmonary by VATS or RATS

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 TS6M;
  • Patient under tutorship or curatorship;
  • Pregnant woman.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: boujibar fairuz, PT 0033751669077 ext +33 fairuz.boujibar@chu-rouen.fr
Contact: Baste Jean-Marc, Pr jean-marc.baste@chu-rouen.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03824977
Other Study ID Numbers 2018-A02694-51
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Rouen
Study Sponsor University Hospital, Rouen
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Rouen
Verification Date January 2019