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

Completed

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

• Registration Number: NCT05669196
• Lead Sponsor: Hacettepe University

Brief 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).

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 Timeline

• Study Start: 2021-01-04
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-27
• Study First Submitted: 2022-10-19
• Status Verified: 2022-11
• Study First Submitted QC: 2022-12-27
• Last Update Submitted: 2022-12-27
• Study First Posted: 2022-12-30
• Last Update Posted: 2022-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory muscle strength (inspiration) change	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.
Respiratory muscle strength (expiration) change	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 Outcome Measures

Name	Time	Method
Functional exercise capacity	15-20 days after discharge.	6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.
Diaphragmatic thickness	15-20 days after discharge.	Ultrasound will be used to measure diaphragmatic thickness.
Postoperative Pulmonary Complication	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.
Postoperative pain	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.
Dyspnea	15-20 days after discharge.	Dyspnea will be evaulate by Modifiye Medical Research Council Dyspnea Scale (mMRC).
Pulmonary function (FEV1)	15-20 days after discharge.	Pulmonary function will be evaulate by pulmonary function test. FEV1 will be measured in liter.
Pulmonary function (FVC)	15-20 days after discharge.	Pulmonary function will be evaulate by pulmonary function test. FVC will be measured in liter.
Pulmonary function (FEF25-75)	15-20 days after discharge.	Pulmonary function will be evaulate by pulmonary function test. FEF25-75 will be measured in liter.
Pulmonary function (PEF)	15-20 days after discharge.	Pulmonary function will be evaulate by pulmonary function test. PEF will be measured in liter.
Functional Status	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.
Anxiety and Depression	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey