Thoracic Surgery Clinical Trial
Official title:
Evaluation of Respiratory Muscle Strength, Diaphragmatic Thickness and Functional Exercise Capacity in Lobectomy Surgeries With Thoracotomy and VATS
NCT number | NCT05669196 |
Other study ID # | KA-19084 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 4, 2021 |
Est. completion date | December 27, 2021 |
Verified date | November 2022 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 42 |
Est. completion date | December 27, 2021 |
Est. primary completion date | December 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Having an orthopedic and neurological condition that prevents walking, - Having undergone any surgery on the thoracic wall, - Diagnosed with small cell lung cancer. |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | The day before the operation. | |
Primary | 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. | 15-20 days after discharge. | |
Primary | 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. | The day before the operation. | |
Primary | 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. | 15-20 days after discharge. | |
Secondary | Functional exercise capacity | 6-minute walk test (6MWT) will be used to evaluate functional exercise capacity. | The day before the operation. | |
Secondary | Functional exercise capacity | 6-minute walk test (6MWT) will be used to evaluate functional exercise capacity. | 15-20 days after discharge. | |
Secondary | Diaphragmatic thickness | Ultrasound will be used to measure diaphragmatic thickness. | The day before the operation. | |
Secondary | Diaphragmatic thickness | Ultrasound will be used to measure diaphragmatic thickness. | 15-20 days after discharge. | |
Secondary | 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. | Postoperative first-fifth days. | |
Secondary | 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. | The operative day after the operation. | |
Secondary | 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. | Postoperative first-fifth days. | |
Secondary | 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. | 15-20 days after discharge. | |
Secondary | Dyspnea | Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC). | The day before the operation. | |
Secondary | Dyspnea | Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC). | 15-20 days after discharge. | |
Secondary | Pulmonary function (FEV1) | Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter. | The day before the operation. | |
Secondary | Pulmonary function (FEV1) | Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter. | 15-20 days after discharge. | |
Secondary | Pulmonary function (FVC) | Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter. | The day before the operation. | |
Secondary | Pulmonary function (FVC) | Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter. | 15-20 days after discharge. | |
Secondary | Pulmonary function (FEF25-75) | Pulmonary function will be evaulate by pulmonary function test. FEF25-75 will be measured in liter. | The day before the operation. | |
Secondary | Pulmonary function (FEF25-75) | Pulmonary function will be evaulate by pulmonary function test. FEF25-75 will be measured in liter. | 15-20 days after discharge. | |
Secondary | Pulmonary function (PEF) | Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter. | The day before the operation. | |
Secondary | Pulmonary function (PEF) | Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter. | 15-20 days after discharge. | |
Secondary | Functional Status | Karnofsky Performance Status Scale will be used to evaluate functional status. It will be used i to assess the preoperative condition. | The day before the operation. | |
Secondary | 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. | Postoperative first-fifth days. |
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