The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions

This study evaluates the effect of breast reconstruction surgery on respiratory functions. 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.

Study Overview

• Status: Unknown
• Conditions: Breast Reconstruction; Respiratory Function
• Intervention / Treatment: Procedure: respiratory function tests

Detailed Description

Breast reconstruction surgery using tissue expander and implant technique is the most common breast reconstruction surgery. During this procedure, the surgeon will insert a silicone expander under the Pectoralis Major muscle. In order to fully cover the expander, the surgeon will detach the Serratus Anterior [SA] muscle from its natural attachments in the rib cage and will attach the free edges to the lateral edge of the Pectoralis Major muscle. After the wound is healed, a gradual inflation of the expander with a physiological fluid will be done by injecting the fluid into a subcutaneous filling port connected to the expander by silicone tubing. When the tissues around the expander will reach the required size, the tissue expander can be replaced by a permanent silicone implant.

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.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Yaron Har-Shai, Proffesor; Phone Number: 0507866206; Email: yaron07@yahoo.com
• Study Contact Backup: Name: Raviv Allon; Phone Number: 0523460305; Email: ravivallon@gmail.com

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

patients elected for breast reconstruction surgery using tissue expander-implant technique

Description

Inclusion Criteria:

• all subjects were elected for a unilateral or bilateral breast reconstruction using tissue expander by the Oncoplastic Committee of the plastic surgery unit in Carmel Medical Center.
• all subjects agrees to enroll in research

Exclusion Criteria:

• subject is in a mental or physical condition that does not allow her to go through respiratory function tests.
• subject was found with a respiratory disfunction or disease in the first respiratory function tests.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: 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	Procedure: respiratory function tests; FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity -FVC	Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort	a month prior to surgery
Forced expiratory volume at one second -FEV1	Volume that has been exhaled at the end of the first second of forced expiration	a month prior to surgery
Maximum voluntary ventilation-MVV	Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort	a month prior to surgery
Functional residual capacity-FRC	Functional residual capacity: the volume in the lungs at the end-expiratory position	a month prior to surgery
Residual volume -RV	Residual volume: the volume of air remaining in the lungs after a maximal exhalation.	a month prior to surgery.
Total lung capacity-TLC	Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.	a month prior to surgery.
Maximal inspiratory pressure-MIP	Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece	a month prior to surgery.
Maximal expiratory pressure-MEP	Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.	a month prior to surgery.
Forced vital capacity -FVC	Forced vital capacity: the determination of the vital capacity from a maximally forced	a month after surgery
Forced vital capacity -FVC	Forced vital capacity: the determination of the vital capacity from a maximally forced	three months after surgery
Forced expiratory volume at one second -FEV1	Volume that has been exhaled at the end of the first second of forced expiration	a month after surgery
Forced expiratory volume at one second -FEV1	Volume that has been exhaled at the end of the first second of forced expiration	three months after surgery
Maximum voluntary ventilation-MVV	Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort	a month after surgery
Maximum voluntary ventilation-MVV	Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort	three months after surgery
Functional residual capacity-FRC	Functional residual capacity: the volume in the lungs at the end-expiratory position	a month after surgery
Functional residual capacity-FRC	Functional residual capacity: the volume in the lungs at the end-expiratory position	three months after surgery
Residual volume -RV	Residual volume: the volume of air remaining in the lungs after a maximal exhalation.	a month after surgery
Residual volume -RV	Residual volume: the volume of air remaining in the lungs after a maximal exhalation.	three months after surgery
Total lung capacity-TLC	Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.	a month after surgery.
Total lung capacity-TLC	Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.	three months after surgery.
Maximal inspiratory pressure-MIP	Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece	a month after surgery
Maximal inspiratory pressure-MIP	Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece	three months after surgery.
Maximal expiratory pressure-MEP	Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.	a month after surgery.
Maximal expiratory pressure-MEP	Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.	three months after surgery.

Collaborators and Investigators

• Sponsor: Yaron Har-Shai
• Investigators: Principal Investigator: Yaron Har-Shai, Proffesor, Carmel Medical Center-Israel

Publications and helpful links

General Publications

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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.
• Lomax M, Tasker L, Bostanci O. An electromyographic evaluation of dual role breathing and upper body muscles in response to front crawl swimming. Scand J Med Sci Sports. 2015 Oct;25(5):e472-8. doi: 10.1111/sms.12354. Epub 2014 Dec 30.
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• Ogata H, Arimitsu T, Matsuura R, Yunoki T, Horiuchi M, Yano T. Relationship between oxygenation in inactive biceps brachii muscle and hyperventilation during leg cycling. Physiol Res. 2007;56(1):57-65. doi: 10.33549/physiolres.930888. Epub 2006 Feb 23.
• 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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• 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.
• Cerqueira EP, Garbellini D. Electromyographic study of the pectoralis major, serratus anterior and external oblique muscles during respiratory activity in humans. Electromyogr Clin Neurophysiol. 1999 Apr-May;39(3):131-7.
• Chawla AK, Kachnic LA, Taghian AG, Niemierko A, Zapton DT, Powell SN. Radiotherapy and breast reconstruction: complications and cosmesis with TRAM versus tissue expander/implant. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):520-6. doi: 10.1016/s0360-3016(02)02951-6.
• Fischer JP, Wes AM, Nelson JA, Basta M, Rohrbach JI, Wu LC, Serletti JM, Kovach SJ. Propensity-matched, longitudinal outcomes analysis of complications and cost: comparing abdominal free flaps and implant-based breast reconstruction. J Am Coll Surg. 2014 Aug;219(2):303-12. doi: 10.1016/j.jamcollsurg.2014.02.028. Epub 2014 Apr 8.
• Gallistel CR. The importance of proving the null. Psychol Rev. 2009 Apr;116(2):439-53. doi: 10.1037/a0015251.
• GRONBAEK P, SKOUBY AP. The activity pattern of the diaphragm and some muscles of the neck and trunk in chronic asthmatics and normal controls. A comparative electromyographic study. Acta Med Scand. 1960 Dec 20;168:413-25. doi: 10.1111/j.0954-6820.1960.tb06672.x. No abstract available.
• JEFFERSON NC, OGAWA T, SYLEOS C, ZAMBETOGLOU A, NECHELES H. Restoration of respiration by nerve anastomosis. Am J Physiol. 1960 May;198:931-3. doi: 10.1152/ajplegacy.1960.198.5.931. No abstract available.
• Johnson BD, Babcock MA, Suman OE, Dempsey JA. Exercise-induced diaphragmatic fatigue in healthy humans. J Physiol. 1993 Jan;460:385-405. doi: 10.1113/jphysiol.1993.sp019477.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Respiratory Function Tests; Tissue Expander; Serratus Anterior; Accessory Respiratory
• Other Study ID Numbers: CMC-15-0029-CTIL