- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805723
Effects of Surgery Types in Patients With Pulmonary Nodules
Comparison of Video-Assisted Thoracoscopy Surgery and Thoracotomy on Cardiorespiratory Parameters in Patients With Pulmonary Nodules
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Patients with pulmonary nodule scheduled VATS
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. |
Video-assisted thoracoscopic surgery is a minimal invasive technique in which used to diagnose or treat for lung diseases. During this surgery, one or two small incisions are opened via camera and surgical instruments in patient's chest wall. Thus, less muscle and nerve tissue are damaged. Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung. |
Experimental: Patients with pulmonary nodule scheduled thoracotomy
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. |
Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax.
During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pulmonary function test (Forced expiratory volume in one second)
Time Frame: first day
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Forced expiratory volume in one second was evaluated with spirometry according American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
The value was represented as percentages.
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first day
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Pulmonary function test (Forced vital capacity)
Time Frame: first day
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Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria.
The value was represented as percentages.
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first day
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Pulmonary function test (Forced expiratory volume in one second/Forced vital capacity)
Time Frame: first day
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Forced expiratory volume in one second/Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria.
The value was represented as percentages.
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first day
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Pulmonary function test (Peak expiratory flow)
Time Frame: first day
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Peak expiratory flow was evaluated with spirometry according to ATS and ERS criteria.
The value was represented as percentages.
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first day
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Pulmonary function test (Flow rate 25-75% of forced expiratory volume)
Time Frame: first day
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Flow rate 25-75% of forced expiratory volume was evaluated with spirometry according to ATS and ERS criteria.
The value was represented as percentages.
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first day
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6-minute walk test
Time Frame: first day
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6-minute walk test were used to assess functional exercise capacity according to the guidelines.
The test was repeated twice in the same day with 30 min interval.
The highest distance was recorded for analysis.
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first day
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6-minute stepper test
Time Frame: second day
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6-minute stepper test were used to assess functional exercise capacity according to the guidelines.
The height of the stepper used for test was 20 cm.
A cycle of up and down was define as one step.
The number of steps was recorded for analysis.
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second day
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Physical activity assessment
Time Frame: second day
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Total energy expenditure (joules/day), active energy expenditure (>3.0 metabolic equivalents (METs)) (joules/day), physical activity duration (>3.0 METs) (min/day), average MET (METs/day), number of steps (steps/day), lying down (min/day) and sleeping duration (min/day) were measured to interpret the physical activity level of the patients via metabolic holter device.
The metabolic holter was worn over triceps brachii muscle of non-dominant extremity for two consecutive days.
The patients' activity level were categorized according to number of steps and average MET sums.
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second day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inspiratory muscle strength test
Time Frame: first day
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Maximal inspiratory pressure (MIP) was performed to evaluate respiratory muscle strength.
Evaluation was done by using portable mouth pressure device accordance with the guidelines.
The MIP was measured at residual volume after maximal expiration.
The measurements were repeated at least seven times for technically acceptable value.
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first day
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Expiratory muscle strength test
Time Frame: first day
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Maximal expiratory pressure (MEP) was performed to evaluate respiratory muscle strength.
Evaluation was done by using portable mouth pressure device accordance with the guidelines.
The MEP was measured from total lung capacity after maximal inspiration.
The measurements were repeated at least seven times for technically acceptable value.
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first day
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Peripheral muscle strength test
Time Frame: first day
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Shoulder abduction, shoulder flexion, elbow extension, quadriceps femoris muscle strength and hand grip strength were evaluated using a hand held dynamometer.
The measurements of each muscle were repeated bilaterally three times.
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first day
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Inspiratory muscle endurance test
Time Frame: second day
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Inspiratory muscle endurance test were performed using respiratory muscle trainer (POWERbreathe) according to incremental threshold loading test protocol.
The endurance test was started at thirty percentage of MIP and each two minutes the load of test was increased by ten percentage of MIP.
The highest percentage of MIP could be reached and sustained for at least 1 min was defined as maximal load and time were recorded for analysis.
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second day
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Modified borg scale
Time Frame: first and second day
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This scale was used to evaluate dyspnea and fatigue perception during 6-minute walk test and 6-minute stepper test.
It was scored between 0 and 10.
The lowest value was 0 which was meant no dyspnea or fatigue and the highest value was 10 which was meant worse and severe dyspnea and fatigue.
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first and second day
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Quality of life scale
Time Frame: first day
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European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0
(Turkish version of scale) were used.
The questionnaire comprise of 30 items in which five scales and several single items are graded from 1 (not at all) to 4 (very much) except for 29-30 items.
All scales and items' scores are expressed by transforming to a 0-100 scale.
Higher values except symptom scale represent higher quality of life.
The minimum value was '0' and the maximum value was '100'.
The highest value was meant better quality of life.
The highest value for symptom scale was meant worse symptom.
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first day
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Fatigue
Time Frame: second day
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Fatigue severity scale (Turkish version of scale) were applied.
This one-dimensional scale compose of nine items scored between 1 (completely disagree) and 7 (completely agree).
The minimum total value was 7 and the maximum total value was 63.
The cut-off value for severe fatigue was 36 and the highest total value is meant severe fatigue.
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second day
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Dyspnea perception
Time Frame: first day
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The Modified Medical Research Council dyspnea scale were performed to determine dyspnea perception during daily living activities.
This categorical scale consisting of five expressions are scored from '0' to '4'.
The minimum value was 0 which means no complain about dyspnea apart from strenuous exercise; the maximum value was 4 which means too breathless for leaving the house or dyspnea while getting dressed.
The highest value was refered to severe shortness of breath during activities of daily living.
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first day
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Pain severity
Time Frame: second day
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To evaluate pain severity, visual analog scale were used.
The minimum value was 0 mm (no pain) and the maximum value was 100 mm (worst pain).
The highest score was 100 mm which was meant worse pain severity.
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second day
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ece BAYTOK, MsC., Gazi University
- Principal Investigator: Zeliha ÇELİK, MsC., Gazi University
- Principal Investigator: Merve ŞATIR TÜRK, MD., Gazi University
- Principal Investigator: İsmail Cüneyt KURUL, Prof. Dr., Gazi University
Publications and helpful links
General Publications
- Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
- Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips M, Sanders LH, Hill K. Impairments after curative intent treatment for non-small cell lung cancer: a comparison with age and gender-matched healthy controls. Respir Med. 2015 Oct;109(10):1332-9. doi: 10.1016/j.rmed.2015.08.015. Epub 2015 Aug 29.
- Nagamatsu Y, Maeshiro K, Kimura NY, Nishi T, Shima I, Yamana H, Shirouzu K. Long-term recovery of exercise capacity and pulmonary function after lobectomy. J Thorac Cardiovasc Surg. 2007 Nov;134(5):1273-8. doi: 10.1016/j.jtcvs.2007.06.025.
- Kaseda S, Aoki T, Hangai N, Shimizu K. Better pulmonary function and prognosis with video-assisted thoracic surgery than with thoracotomy. Ann Thorac Surg. 2000 Nov;70(5):1644-6. doi: 10.1016/s0003-4975(00)01909-3.
- Cheng X, Onaitis MW, D'amico TA, Chen H. Minimally Invasive Thoracic Surgery 3.0: Lessons Learned From the History of Lung Cancer Surgery. Ann Surg. 2018 Jan;267(1):37-38. doi: 10.1097/SLA.0000000000002405. No abstract available.
- Upham TC, Onaitis MW. Video-assisted thoracoscopic surgery versus robot-assisted thoracoscopic surgery versus thoracotomy for early-stage lung cancer. J Thorac Cardiovasc Surg. 2018 Jul;156(1):365-368. doi: 10.1016/j.jtcvs.2018.02.064. Epub 2018 Mar 2. No abstract available.
- Park TY, Park YS. Long-term respiratory function recovery in patients with stage I lung cancer receiving video-assisted thoracic surgery versus thoracotomy. J Thorac Dis. 2016 Jan;8(1):161-8. doi: 10.3978/j.issn.2072-1439.2016.01.14.
- Granger CL, Parry SM, Edbrooke L, Denehy L. Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer - future directions for physiotherapy management. Physiotherapy. 2016 Sep;102(3):256-63. doi: 10.1016/j.physio.2015.10.007. Epub 2015 Oct 23.
- Schwartz RM, Yip R, Flores RM, Olkin I, Taioli E, Henschke C; I-ELCAP Investigators. The impact of resection method and patient factors on quality of life among stage IA non-small cell lung cancer surgical patients. J Surg Oncol. 2017 Feb;115(2):173-180. doi: 10.1002/jso.24478. Epub 2016 Oct 28.
- Nomori H, Kobayashi R, Fuyuno G, Morinaga S, Yashima H. Preoperative respiratory muscle training. Assessment in thoracic surgery patients with special reference to postoperative pulmonary complications. Chest. 1994 Jun;105(6):1782-8. doi: 10.1378/chest.105.6.1782.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gazi University 509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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