The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions
NCT ID: NCT02491762
Last Updated: 2015-07-15
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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UNKNOWN
45 participants
OBSERVATIONAL
2015-08-31
2017-08-31
Brief Summary
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Detailed Description
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The SA attachments are to the superior angle, medial border and inferior angle of the scapula and to the first to eighth ribs. Its main functions are stabilization and protraction of the scapula and turning the glenoid cavity superiorly in abduction of arms. In addition, the SA is an accessory respiratory muscle: when the scapula is stabilized, its contraction will lift the rib cage in order to help breathing. The importance of the SA in breathing has been examined since the late 19th century and until this day it is not fully agreed upon. Most studies agree that the SA major role in breathing is in deep breaths and is that the muscle is most effective for this purpose when arms are lifted.
Since breast reconstruction procedure includes detachment of the SA from the rib cage and there by canceling its respiratory function, an examination of the respiratory functions before and after the procedure is in order to determine whether or not the overall respiratory functions had been effected.
45 patients elected for unilateral or bilateral breast reconstruction surgery will go through respiratory function examinations a month prior to the surgery, one month after surgery and three months after surgery. The examinations will include the following tests: Spirometry: FVC, FEV1, MVV. Lung capacities: FRC, RV, TLC. Breathing muscle strength: MIP, MEP.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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bilateral
bilateral breast construction candidates will go through respiratory function tests a month prior to surgery, a month after surgery and three months after surgery
respiratory function tests
FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP
unilateral
unilateral breast construction candidates will go through respiratory function tests a month prior to surgery, a month after surgery and three months after surgery
respiratory function tests
FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP
Interventions
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respiratory function tests
FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP
Eligibility Criteria
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Inclusion Criteria
* all subjects agrees to enroll in research
Exclusion Criteria
* subject was found with a respiratory disfunction or disease in the first respiratory function tests.
18 Years
90 Years
FEMALE
Yes
Sponsors
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Yaron Har-Shai
OTHER
Responsible Party
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Yaron Har-Shai
Clinical Professor Yaron Har-Shai
Principal Investigators
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Yaron Har-Shai, Proffesor
Role: PRINCIPAL_INVESTIGATOR
Carmel Medical Center-Israel
Locations
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Carmel Medical Center
Haifa, , Israel
Countries
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Central Contacts
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References
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Legrand R, Prieur F, Marles A, Nourry C, Lazzari S, Blondel N, Mucci P. Respiratory muscle oxygenation kinetics: relationships with breathing pattern during exercise. Int J Sports Med. 2007 Feb;28(2):91-9. doi: 10.1055/s-2006-924056. Epub 2006 Jul 12.
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Ogata H, Reyihan A, Yano T. Kinetics of oxygenation in inactive forearm muscle during ramp leg cycling. J Physiol Anthropol Appl Human Sci. 2004 Jan;23(1):7-17. doi: 10.2114/jpa.23.7.
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TOKIZANE T, KAWAMATA K, TOKIZANE H. Electromyographic studies on the human respiratory muscles; studies on the activity pattern of neuromuscular units. Jpn J Physiol. 1952 Feb;2(3):232-47. doi: 10.2170/jjphysiol.2.232. No abstract available.
Tsoi B, Ziolkowski NI, Thoma A, Campbell K, O'Reilly D, Goeree R. Systematic review on the patient-reported outcomes of tissue-expander/implant vs autologous abdominal tissue breast reconstruction in postmastectomy breast cancer patients. J Am Coll Surg. 2014 May;218(5):1038-48. doi: 10.1016/j.jamcollsurg.2014.02.011. Epub 2014 Feb 19. No abstract available.
Wang L, Yoshikawa T, Hara T, Nakao H, Suzuki T, Fujimoto S. Which common NIRS variable reflects muscle estimated lactate threshold most closely? Appl Physiol Nutr Metab. 2006 Oct;31(5):612-20. doi: 10.1139/h06-069.
Cannon DT, Grout SL, May CA, Strom SD, Wyckoff KG, Cipriani DJ, Buono MJ. Recruitment of the serratus anterior as an accessory muscle of ventilation during graded exercise. J Physiol Sci. 2007 Apr;57(2):127-31. doi: 10.2170/physiolsci.RP001807. Epub 2007 Apr 6.
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Other Identifiers
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CMC-15-0029-CTIL
Identifier Type: -
Identifier Source: org_study_id
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