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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Respiratory Function, Breast Reconstruction

Intervention / Treatment
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* Procedure: respiratory function tests


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bilateral<br>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<br>* FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP<br>|
| unilateral<br>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<br>* FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serratus Anterior, Accessory Respiratory, Tissue Expander, Respiratory Function Tests