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

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).

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery; Respiratory Muscles; Video Assisted Thoracoscopic Surgery

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercise capacity	6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.	The day before the operation.
Functional exercise capacity	6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.	15-20 days after discharge.
Diaphragmatic thickness	Ultrasound will be used to measure diaphragmatic thickness.	The day before the operation.
Diaphragmatic thickness	Ultrasound will be used to measure diaphragmatic thickness.	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.	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.	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.	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.	15-20 days after discharge.
Dyspnea	Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC).	The day before the operation.
Dyspnea	Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC).	15-20 days after discharge.
Pulmonary function (FEV1)	Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter.	The day before the operation.
Pulmonary function (FEV1)	Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter.	15-20 days after discharge.
Pulmonary function (FVC)	Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter.	The day before the operation.
Pulmonary function (FVC)	Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter.	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.	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.	15-20 days after discharge.
Pulmonary function (PEF)	Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter.	The day before the operation.
Pulmonary function (PEF)	Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter.	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.	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.	Postoperative first-fifth days.

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Funda Sirakaya, MsC, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 27, 2021

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Lung cancer, functional capacity
• Other Study ID Numbers: KA-19084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No