Effects of Surgery Types in Patients With Pulmonary Nodules

Gazi University

Status: Completed

Conditions: Pulmonary Nodule

Treatments: Procedure: Thoracotomy; Procedure: VATS

Study type: Interventional

Funder types: Other

Identifiers

NCT04805723

Gazi University 509

Details and patient eligibility

About

The investigators aimed to compare the pre-post operative effects of video-assisted thoracoscopy surgery (VATS) and thoracotomy on pulmonary function, exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain in patients with pulmonary nodules.

Full description

According to global cancer statistics, lung cancer accounts for 11.6% of all cancer cases and it is the most common type of cancer in the world. Surgery is the primary treatment approach, especially in early stages lung cancer. Cardiopulmonary fitness of patients with lung cancer is lower than healthy individuals due to the disease itself and treatments. Pulmonary function, exercise capacity and physical activity level are affected in lung cancer depending on the resected lung tissue and the type of surgery. VATS and thoracotomy surgeries, which are the most preferred techniques in lung cancer, have advantages and disadvantages over each other. There are few studies compared the early effects of two surgeries on the pulmonary function, exercise capacity, physical activity, quality of life and fatigue. And also, no study compared the effects of two surgeries on respiratory muscle endurance and peripheral muscle strength, previously.

According to sample size calculation, at least 15 patients with pulmonary lesion both VATS and thoracotomy groups would be included in the study. The demographic, physical and physiological characteristics were recorded from the patient files. Pulmonary function, functional exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain were evaluated pre and two weeks after postoperative term. Primary outcomes were pulmonary function, functional exercise capacity and physical activity level. Secondary outcomes were respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain.

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being between 18-80 years of age,
• Patients with pulmonary nodule who were planned lobectomy surgery with one of VATS or thoracotomy techniques,
• Being able to walk,

Exclusion criteria

• Any type of surgery planned except lobectomy,
• Having heart failure or atrial fibrillation,
• Having acute viral infections during all assessment,
• History of acute myocard infarction within last six months,
• Uncontrolled diabetes or hypertension,
• Having orthopedic, neurological and psychological disorders that influence the results of study.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Patients with pulmonary nodule scheduled VATS

Experimental group

Description:

Patients with pulmonary nodule scheduled VATS were included in this study. Inclusion and exclusion criteria were considered. Pulmonary function (spirometry), functional exercise capacity (6-minute walk test (6-MWT); 6-minute stepper test (6-MST)), physical activity level (metabolic holter), respiratory (maximal inspiratory and expiratory pressures (MIP-MEP); mouth pressure device) and peripheral muscle strength (dynamometer), inspiratory muscle endurance (incremental loading test), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)), fatigue (Fatigue Severity Scale), dyspnea perception (Modified Medical Research Council dyspnea scale (MMRC)) and pain severity (Visual Analog Scale) were assessed before VATS and average two weeks after surgery.

Treatment:

Procedure: VATS

Patients with pulmonary nodule scheduled thoracotomy

Experimental group

Description:

Patients with pulmonary nodule scheduled thoracotomy were included in this study. Inclusion and exclusion criteria were considered. Pulmonary function (spirometry), functional exercise capacity (6-minute walk test (6-MWT); 6-minute stepper test (6-MST)), physical activity level (metabolic holter), respiratory (maximal inspiratory and expiratory pressures (MIP-MEP); mouth pressure device) and peripheral muscle strength (dynamometer), inspiratory muscle endurance (incremental loading test), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)), fatigue (Fatigue Severity Scale), dyspnea perception (Modified Medical Research Council dyspnea scale (MMRC)) and pain severity (Visual Analog Scale) were assessed before VATS and average two weeks after surgery.

Treatment:

Procedure: Thoracotomy