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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

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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