Effects of Surgery Types in Patients With Pulmonary Nodules
NCT ID: NCT04805723
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2018-07-10
2020-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
VATS
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.
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
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.
Interventions
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VATS
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.
Thoracotomy
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with pulmonary nodule who were planned lobectomy surgery with one of VATS or thoracotomy techniques,
* Being able to walk,
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Gazi University
OTHER
Responsible Party
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Meral Boşnak Güçlü
Prof.Dr
Principal Investigators
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Ece BAYTOK, MsC.
Role: STUDY_CHAIR
Gazi University
Zeliha ÇELİK, MsC.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Merve ŞATIR TÜRK, MD.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Ali ÇELİK, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
İsmail Cüneyt KURUL, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Meral Boşnak GÜÇLÜ, Prof. Dr.
Role: STUDY_DIRECTOR
Gazi University
Locations
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Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, , Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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Gazi University 509
Identifier Type: -
Identifier Source: org_study_id
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