Diaphragmatic Thickness and Functional Exercise Capacity in Lobectomy Surgeries With Thoracotomy and VATS

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05669196
• Other study ID #: KA-19084
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Respiratory Muscles
• Thoracic Surgery
• Video Assisted Thoracoscopic Surgery

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.