Effects of Surgery Types in Patients With Pulmonary Nodules

NCT04805723 | Completed

• 1 other identifier: Gazi University 509
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Nodule

Keywords

pulmonary nodule; pulmonary function; functional exercise capacity; physical activity; respiratory muscle strength; respiratory muscle endurance; quality of life

Outcome Measures

Primary Outcomes (8)

• 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.

  first day

• 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.

  first day

• 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.

  first day

• 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.

  first day

• 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.

  first day

• 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.

  first day

• 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.

  second day

• 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.

  second day

Secondary Outcomes (9)

• Inspiratory muscle strength test

  first day

• Expiratory muscle strength test

  first day

• Peripheral muscle strength test

  first day

• Inspiratory muscle endurance test

  second day

• Modified borg scale

  first and second day

Study Arms (2)

Patients with pulmonary nodule scheduled VATS

EXPERIMENTAL

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.

Procedure: VATS

Patients with pulmonary nodule scheduled thoracotomy

EXPERIMENTAL

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.

Procedure: Thoracotomy

Interventions

VATS PROCEDURE

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 VATS

Thoracotomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 30207593 RESULT

• 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.

  PMID: 26342839 RESULT

• 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.

  PMID: 17976462 RESULT

• 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.

  PMID: 11093502 RESULT

• 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.

  PMID: 28692471 RESULT

• 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.

  PMID: 29921098 RESULT

• 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.

  PMID: 26904225 RESULT

• 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.

  PMID: 26597694 RESULT

• 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.

  PMID: 27790715 RESULT

• 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.

  PMID: 8205877 RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Thoracic Surgery, Video-Assisted; Thoracotomy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Ece BAYTOK, MsC.

  Gazi University

  STUDY CHAIR

• Zeliha ÇELİK, MsC.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Merve ŞATIR TÜRK, MD.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ali ÇELİK, Assoc. Prof.

  Gazi University

  PRINCIPAL INVESTIGATOR

• İsmail Cüneyt KURUL, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral Boşnak GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 18, 2021
• Study Start: July 10, 2018
• Primary Completion: July 25, 2019
• Study Completion: January 1, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)