Video Assisted Thoracoscopic SurgeryNCT05669196
Diaphragmatic Thickness and Functional Exercise Capacity in Lobectomy Surgeries With Thoracotomy and VATS
An observational study of Video Assisted Thoracoscopic Surgery and Thoracic Surgery, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy. Different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Video Assisted Thoracoscopic Surgery, Thoracic Surgery, Respiratory Muscles
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 27 Dec 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with lung cancer who met the inclusion criteria in the 18-75 age range participated in the study. According to the surgical intervention methods, the patients in our study; divided into three groups as standard thoracotomy, muscle sparing thoracotomy, and VATS.
Who may be able to join
- Being a lung cancer patient scheduled for standard thoracotomy, muscle sparing thoracotomy, or lobectomy with VATS,
- Being clinically stable,
- Volunteering to participate in the study,
- be between the ages of 18-75,
- To be cooperative in the tests to be done.
Who cannot join
- Having an orthopedic and neurological condition that prevents walking, - Having undergone any surgery on the thoracic wall,
- Diagnosed with small cell lung cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Respiratory Muscle Strength, Diaphragmatic Thickness and Functional Exercise Capacity in Lobectomy Surgeries With Thoracotomy and VATS
The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy. Different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. The aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (VATS).
Read the detailed description
The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy. Different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. The aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (VATS). In this study we will evaluate respiratory muscle strength, functional exercise capacity, diaphragmatic thickness, postoperative pulmonary complications, pain, dyspnea, pulmonary function, functional status, anxiety and depression.
- Keywords
- Lung cancer, functional capacity
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| standard thoracotomy group | Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with standard thoracotomy | |
| muscle sparing thoracotomy group | Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with muscle sparing thoracotomy | |
| VATS group | Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength (inspiration) change
Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values. Preoperative and postoperative value differences will be calculated.
Measured: The day before the operation.
Respiratory muscle strength (inspiration) change
Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values. Preoperative and postoperative value differences will be calculated.
Measured: 15-20 days after discharge.
Respiratory muscle strength (expiration) change
Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values. Preoperative and postoperative value differences will be calculated.
Measured: The day before the operation.
Respiratory muscle strength (expiration) change
Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values. Preoperative and postoperative value differences will be calculated.
Measured: 15-20 days after discharge.
Secondary outcomes (20)
Functional exercise capacity
6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.
Measured: The day before the operation.
Functional exercise capacity
6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.
Measured: 15-20 days after discharge.
Diaphragmatic thickness
Ultrasound will be used to measure diaphragmatic thickness.
Measured: The day before the operation.
Diaphragmatic thickness
Ultrasound will be used to measure diaphragmatic thickness.
Measured: 15-20 days after discharge.
Postoperative Pulmonary Complication
Postoperative pulmonary complications will be evaulate by Melbourne Group Scale. If more than 4 parameters are positive, it will be considered as having postoperative pulmonary complication.
Measured: Postoperative first-fifth days.
Postoperative pain
Visual anolog scala will be used to measure pain. Zero is considered as no pain an ten s considered as no maximal pain.
Measured: The operative day after the operation.
Postoperative pain
Visual anolog scala will be used to measure pain. Zero is considered as no pain an ten s considered as no maximal pain.
Measured: Postoperative first-fifth days.
Postoperative pain
Visual anolog scala will be used to measure pain. Zero is considered as no pain an ten s considered as no maximal pain.
Measured: 15-20 days after discharge.
Dyspnea
Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC).
Measured: The day before the operation.
Dyspnea
Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC).
Measured: 15-20 days after discharge.
Pulmonary function (FEV1)
Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter.
Measured: The day before the operation.
Pulmonary function (FEV1)
Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter.
Measured: 15-20 days after discharge.
Pulmonary function (FVC)
Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter.
Measured: The day before the operation.
Pulmonary function (FVC)
Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter.
Measured: 15-20 days after discharge.
Pulmonary function (FEF25-75)
Pulmonary function will be evaulate by pulmonary function test. FEF25-75 will be measured in liter.
Measured: The day before the operation.
Pulmonary function (FEF25-75)
Pulmonary function will be evaulate by pulmonary function test. FEF25-75 will be measured in liter.
Measured: 15-20 days after discharge.
Pulmonary function (PEF)
Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter.
Measured: The day before the operation.
Pulmonary function (PEF)
Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter.
Measured: 15-20 days after discharge.
Functional Status
Karnofsky Performance Status Scale will be used to evaluate functional status. It will be used i to assess the preoperative condition.
Measured: The day before the operation.
Anxiety and Depression
Anxiety and depression will be evaulate by Hospital Anxiety and Depression Scale. 7 of the survey questions question depression and 7 of them question anxiety.
Measured: Postoperative first-fifth days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start4 Jan 2021
- Primary completion7 Dec 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Assisted Thoracoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Sirakaya, Hacettepe University
- Investigators
- Funda Sirakaya, MsC, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669196
- Sponsor's protocol ID
- KA-19084
- Status last verified
- Nov 2022
- First submitted
- 19 Oct 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Muscle Strength, Diaphragmatic Thickness and Functional Exercise Capacity in Lobectomy Surgeries With Thoracotomy and VATS
- ClinicalTrials.gov ID
- NCT05669196
- Acronym / sponsor ID
- KA-19084
- Keywords
- Lung cancer, functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 30 Dec 2022 (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.
The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy. Different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. The aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (VATS).
Detailed description
The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy. Different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. The aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (VATS). In this study we will evaluate respiratory muscle strength, functional exercise capacity, diaphragmatic thickness, postoperative pulmonary complications, pain, dyspnea, pulmonary function, functional status, anxiety and depression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard thoracotomy group | – | –Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with standard thoracotomy |
| muscle sparing thoracotomy group | – | –Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with muscle sparing thoracotomy |
| VATS group | – | –Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with lung cancer who met the inclusion criteria in the 18-75 age range participated in the study. According to the surgical intervention methods, the patients in our study; divided into three groups as standard thoracotomy, muscle sparing thoracotomy, and VATS.
Key inclusion criteria (5 listed)
- Being a lung cancer patient scheduled for standard thoracotomy, muscle sparing thoracotomy, or lobectomy with VATS,
- Being clinically stable,
- Volunteering to participate in the study,
- be between the ages of 18-75,
- To be cooperative in the tests to be done.
Key exclusion criteria (2 listed)
- Having an orthopedic and neurological condition that prevents walking, - Having undergone any surgery on the thoracic wall,
- Diagnosed with small cell lung cancer.
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
Respiratory muscle strength (inspiration) change
Time frame: The day before the operation.
Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values. Preoperative and postoperative value differences will be calculated.
Respiratory muscle strength (inspiration) change
Time frame: 15-20 days after discharge.
Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values. Preoperative and postoperative value differences will be calculated.
Respiratory muscle strength (expiration) change
Time frame: The day before the operation.
Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values. Preoperative and postoperative value differences will be calculated.
Respiratory muscle strength (expiration) change
Time frame: 15-20 days after discharge.
Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values. Preoperative and postoperative value differences will be calculated.
20 secondary outcomes
Functional exercise capacity
Time frame: The day before the operation.
Functional exercise capacity
Time frame: 15-20 days after discharge.
Diaphragmatic thickness
Time frame: The day before the operation.
Diaphragmatic thickness
Time frame: 15-20 days after discharge.
Postoperative Pulmonary Complication
Time frame: Postoperative first-fifth days.
Postoperative pain
Time frame: The operative day after the operation.
Postoperative pain
Time frame: Postoperative first-fifth days.
Postoperative pain
Time frame: 15-20 days after discharge.
Dyspnea
Time frame: The day before the operation.
Dyspnea
Time frame: 15-20 days after discharge.
Pulmonary function (FEV1)
Time frame: The day before the operation.
Pulmonary function (FEV1)
Time frame: 15-20 days after discharge.
Pulmonary function (FVC)
Time frame: The day before the operation.
Pulmonary function (FVC)
Time frame: 15-20 days after discharge.
Pulmonary function (FEF25-75)
Time frame: The day before the operation.
Pulmonary function (FEF25-75)
Time frame: 15-20 days after discharge.
Pulmonary function (PEF)
Time frame: The day before the operation.
Pulmonary function (PEF)
Time frame: 15-20 days after discharge.
Functional Status
Time frame: The day before the operation.
Anxiety and Depression
Time frame: Postoperative first-fifth days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Video Assisted Thoracoscopic Surgery
Not yet recruiting
Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection
Thoracic Neoplasms
Recruiting
Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah
Pain, Postoperative Pain
Recruiting
Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia
Postoperative Pain, Thoracic Surgery
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
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.
Funda Sirakaya, MsC principal investigator
Hacettepe University
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 Video Assisted Thoracoscopic Surgery and Thoracic Surgery, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 30 Dec 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (inspiration) change (time frame: The day before the operation.). The study lists 4 primary outcomes in all. 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 30 Dec 2022.