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Completed

NCT Number: NCT05669196

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).

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Key information

Conditions

Video Assisted Thoracoscopic Surgery Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Muscles Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thoracic Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Functional exercise capacity

    Time frame: The day before the operation.

    6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.

  2. Functional exercise capacity

    Time frame: 15-20 days after discharge.

    6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.

  3. Diaphragmatic thickness

    Time frame: The day before the operation.

    Ultrasound will be used to measure diaphragmatic thickness.

  4. Diaphragmatic thickness

    Time frame: 15-20 days after discharge.

    Ultrasound will be used to measure diaphragmatic thickness.

  5. Postoperative Pulmonary Complication

    Time frame: Postoperative first-fifth days.

    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.

  6. Postoperative pain

    Time frame: The operative day after the operation.

    Visual anolog scala will be used to measure pain. Zero is considered as no pain an ten s considered as no maximal pain.

  7. Postoperative pain

    Time frame: Postoperative first-fifth days.

    Visual anolog scala will be used to measure pain. Zero is considered as no pain an ten s considered as no maximal pain.

  8. Postoperative pain

    Time frame: 15-20 days after discharge.

    Visual anolog scala will be used to measure pain. Zero is considered as no pain an ten s considered as no maximal pain.

  9. Dyspnea

    Time frame: The day before the operation.

    Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC).

  10. Dyspnea

    Time frame: 15-20 days after discharge.

    Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC).

  11. Pulmonary function (FEV1)

    Time frame: The day before the operation.

    Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter.

  12. Pulmonary function (FEV1)

    Time frame: 15-20 days after discharge.

    Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter.

  13. Pulmonary function (FVC)

    Time frame: The day before the operation.

    Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter.

  14. Pulmonary function (FVC)

    Time frame: 15-20 days after discharge.

    Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter.

  15. Pulmonary function (FEF25-75)

    Time frame: The day before the operation.

    Pulmonary function will be evaulate by pulmonary function test. FEF25-75 will be measured in liter.

  16. Pulmonary function (FEF25-75)

    Time frame: 15-20 days after discharge.

    Pulmonary function will be evaulate by pulmonary function test. FEF25-75 will be measured in liter.

  17. Pulmonary function (PEF)

    Time frame: The day before the operation.

    Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter.

  18. Pulmonary function (PEF)

    Time frame: 15-20 days after discharge.

    Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter.

  19. Functional Status

    Time frame: The day before the operation.

    Karnofsky Performance Status Scale will be used to evaluate functional status. It will be used i to assess the preoperative condition.

  20. Anxiety and Depression

    Time frame: Postoperative first-fifth days.

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Evaluation of Respiratory Muscle Strength, Diaphragmatic Thickness and Functional Exercise Capacity in Lobectomy Surgeries With Thoracotomy and VATS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2022
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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