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Effects of Surgery Types in Patients With Pulmonary Nodules

Primary Purpose

Pulmonary Nodule

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
VATS
Thoracotomy
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pulmonary Nodule focused on measuring pulmonary nodule, pulmonary function, functional exercise capacity, physical activity, respiratory muscle strength, respiratory muscle endurance, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with pulmonary nodule scheduled VATS

Patients with pulmonary nodule scheduled thoracotomy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Pulmonary function test (Forced expiratory volume in one second)
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.
Pulmonary function test (Forced vital capacity)
Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Pulmonary function test (Forced expiratory volume in one second/Forced vital capacity)
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.
Pulmonary function test (Peak expiratory flow)
Peak expiratory flow was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Pulmonary function test (Flow rate 25-75% of forced expiratory volume)
Flow rate 25-75% of forced expiratory volume was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
6-minute walk test
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.
6-minute stepper test
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.
Physical activity assessment
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.

Secondary Outcome Measures

Inspiratory muscle strength test
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.
Expiratory muscle strength test
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.
Peripheral muscle strength test
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.
Inspiratory muscle endurance test
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.
Modified borg scale
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.
Quality of life scale
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.
Fatigue
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.
Dyspnea perception
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.
Pain severity
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.

Full Information

First Posted
February 28, 2021
Last Updated
March 17, 2021
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04805723
Brief Title
Effects of Surgery Types in Patients With Pulmonary Nodules
Official Title
Comparison of Video-Assisted Thoracoscopy Surgery and Thoracotomy on Cardiorespiratory Parameters in Patients With Pulmonary Nodules
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule
Keywords
pulmonary nodule, pulmonary function, functional exercise capacity, physical activity, respiratory muscle strength, respiratory muscle endurance, quality of life

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with pulmonary nodule scheduled VATS
Arm Type
Experimental
Arm 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.
Arm Title
Patients with pulmonary nodule scheduled thoracotomy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
VATS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Thoracotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary function test (Forced expiratory volume in one second)
Description
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.
Time Frame
first day
Title
Pulmonary function test (Forced vital capacity)
Description
Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Time Frame
first day
Title
Pulmonary function test (Forced expiratory volume in one second/Forced vital capacity)
Description
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.
Time Frame
first day
Title
Pulmonary function test (Peak expiratory flow)
Description
Peak expiratory flow was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Time Frame
first day
Title
Pulmonary function test (Flow rate 25-75% of forced expiratory volume)
Description
Flow rate 25-75% of forced expiratory volume was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Time Frame
first day
Title
6-minute walk test
Description
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.
Time Frame
first day
Title
6-minute stepper test
Description
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.
Time Frame
second day
Title
Physical activity assessment
Description
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.
Time Frame
second day
Secondary Outcome Measure Information:
Title
Inspiratory muscle strength test
Description
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.
Time Frame
first day
Title
Expiratory muscle strength test
Description
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.
Time Frame
first day
Title
Peripheral muscle strength test
Description
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.
Time Frame
first day
Title
Inspiratory muscle endurance test
Description
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.
Time Frame
second day
Title
Modified borg scale
Description
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.
Time Frame
first and second day
Title
Quality of life scale
Description
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.
Time Frame
first day
Title
Fatigue
Description
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.
Time Frame
second day
Title
Dyspnea perception
Description
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.
Time Frame
first day
Title
Pain severity
Description
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.
Time Frame
second day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ece BAYTOK, MsC.
Organizational Affiliation
Gazi University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zeliha ÇELİK, MsC.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Merve ŞATIR TÜRK, MD.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali ÇELİK, Assoc. Prof.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmail Cüneyt KURUL, Prof. Dr.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meral Boşnak GÜÇLÜ, Prof. Dr.
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30207593
Citation
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.
Results Reference
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PubMed Identifier
26342839
Citation
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.
Results Reference
result
PubMed Identifier
17976462
Citation
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.
Results Reference
result
PubMed Identifier
11093502
Citation
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.
Results Reference
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PubMed Identifier
28692471
Citation
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.
Results Reference
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PubMed Identifier
29921098
Citation
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.
Results Reference
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PubMed Identifier
26904225
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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Effects of Surgery Types in Patients With Pulmonary Nodules

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