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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

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.

Condition or disease Intervention/treatment
To Evaluate the Predictive Performance of the 6-minute Stepper Test on the Risk of Complications Diagnostic Test: Six minutes stepper test

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : November 21, 2018
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery


Intervention Details:
  • 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


Primary Outcome Measures :
  1. occurrence of a post-operative complication grade ≥ 2 on the Clavien-Dindo scale within three months after surgery [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824977


Contacts
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Contact: boujibar fairuz, PT 0033751669077 ext +33 fairuz.boujibar@chu-rouen.fr
Contact: Baste Jean-Marc, Pr jean-marc.baste@chu-rouen.fr

Locations
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France
Boujibar , F Recruiting
Rouen, France
Contact: Boujibar         
Sponsors and Collaborators
University Hospital, Rouen

Additional Information:

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03824977     History of Changes
Other Study ID Numbers: 2018-A02694-51
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
lung resection
low technology
six minutes stepper test
sit to stand test
physiotherapy
lung surgery
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases