Thoracic SurgeryNCT03300622
Assessment in Patients After Thoracic Surgery
An observational study of Thoracic Surgery, run by Universidad de Granada at 1 site in Spain.
Trial summary
Lung cancer is the leading cause of death in men and the second in women with a 5 year survival in Europe of less than 15%. One of the methods most used for its treatment is pulmonary resection. The objective of this study is to analyze the clinical profile presented to patients after pulmonary resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and / or women of legal age who are admitted for lung resection, with the approval of the physician responsible, and who sign the informed consent
Who may be able to join
- Patient admitted for lung resection and who sign the informed consent
Who cannot join
- Patients who did not agree to sign informed consent and those who presented other types of problems to be able to adequately carry out the assessment, such as not handling the language.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Department of Physical Therapy
Granada, 18071
Marie Carmen Valenza, PhD, 958242360, cvalenza@ugr.es
Marie Carmen Valenza, PhD
About this study
Official title: Evaluation of Hospitalized Patients After Thoracic Pulmonary Resection Surgery
Lung cancer is the leading cause of death in men and the second in women with a 5 year survival in Europe of less than 15%. One of the methods most used for its treatment is pulmonary resection. The objective of this study is to analyze the clinical profile presented to patients after pulmonary resection.
Read the detailed description
One of the most widely used methods for the treatment of lung cancer is pulmonary resection. The morbidity and mortality of pulmonary resection surgery is conditioned by both the type of intervention and the patient's condition. Functional deterioration is a risk associated with hospitalization in the elderly, with a high prevalence (35-70%) and serious consequences, since in the majority it can lead to the appearance of complications not related to the reason for admission or the specific treatment. It is very important to evaluate the clinical profile of patients after pulmonary resection in order to stablish a more specific repercussion.
- Conditions
- Thoracic Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength in upper and lower limbs
Changes from baseline to postintervention during hospital stay in lower and upper limbs strength. The quadriceps and the hand-grip strength is assessed using a portable dynamometer with a standard protocol allowing three attempts on each side.
Measured: Baseline, up to 1 month
Secondary outcomes (1)
Exercise capacity
Five times sit to stand test (5STS) will be used to assess exercise capacity. 5STS is a simple assessment tool that is feasible in all healthcare settings and involves asking the patient to stand up 5 times for the shortest possible time without arm support.. Saturation and heart rate will be monitored as well as levels of dyspnea and fatigue of the patient.
Measured: Baseline, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Sep 2017
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PT, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300622
- Sponsor's protocol ID
- DF0070UG
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hospitalized Patients After Thoracic Pulmonary Resection Surgery
- ClinicalTrials.gov ID
- NCT03300622
- Acronym / sponsor ID
- DF0070UG
- Conditions
- Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the leading cause of death in men and the second in women with a 5 year survival in Europe of less than 15%. One of the methods most used for its treatment is pulmonary resection. The objective of this study is to analyze the clinical profile presented to patients after pulmonary resection.
Detailed description
One of the most widely used methods for the treatment of lung cancer is pulmonary resection. The morbidity and mortality of pulmonary resection surgery is conditioned by both the type of intervention and the patient's condition. Functional deterioration is a risk associated with hospitalization in the elderly, with a high prevalence (35-70%) and serious consequences, since in the majority it can lead to the appearance of complications not related to the reason for admission or the specific treatment. It is very important to evaluate the clinical profile of patients after pulmonary resection in order to stablish a more specific repercussion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and / or women of legal age who are admitted for lung resection, with the approval of the physician responsible, and who sign the informed consent
Key inclusion criteria (1 listed)
- Patient admitted for lung resection and who sign the informed consent
Key exclusion criteria (1 listed)
- Patients who did not agree to sign informed consent and those who presented other types of problems to be able to adequately carry out the assessment, such as not handling the language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Strength in upper and lower limbs
Time frame: Baseline, up to 1 month
Changes from baseline to postintervention during hospital stay in lower and upper limbs strength. The quadriceps and the hand-grip strength is assessed using a portable dynamometer with a standard protocol allowing three attempts on each side.
1 secondary outcome
Exercise capacity
Time frame: Baseline, up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Carmen Valenza, PT, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD (958248035, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength in upper and lower limbs (time frame: Baseline, up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.