Clinical trial NCT04805723: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Nodule
Keywords: pulmonary nodule
pulmonary function
functional exercise capacity
physical activity
respiratory muscle strength
respiratory muscle endurance
quality of life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Pulmonary function test (Forced expiratory volume in one second)
timeFrame: first day
measure: Pulmonary function test (Forced vital capacity)
timeFrame: first day
measure: Pulmonary function test (Forced expiratory volume in one second/Forced vital capacity)
timeFrame: first day
measure: Pulmonary function test (Peak expiratory flow)
timeFrame: first day
measure: Pulmonary function test (Flow rate 25-75% of forced expiratory volume)
timeFrame: first day
measure: 6-minute walk test
timeFrame: first day
measure: 6-minute stepper test
timeFrame: second day
measure: Physical activity assessment
timeFrame: second day
Secondary outcomes:
measure: Inspiratory muscle strength test
timeFrame: first day
measure: Expiratory muscle strength test
timeFrame: first day
measure: Peripheral muscle strength test
timeFrame: first day
measure: Inspiratory muscle endurance test
timeFrame: second day
measure: Modified borg scale
timeFrame: first and second day
measure: Quality of life scale
timeFrame: first day
measure: Fatigue
timeFrame: second day
measure: Dyspnea perception
timeFrame: first day
measure: Pain severity
timeFrame: second day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Study officials:
affiliation: Gazi University
name: Ece BAYTOK, MsC.
role: STUDY_CHAIR
affiliation: Gazi University
name: Zeliha ÇELİK, MsC.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Merve ŞATIR TÜRK, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Ali ÇELİK, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: İsmail Cüneyt KURUL, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral Boşnak GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.