Breast Reconstruction Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Carmel Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Yaron Har-Shai |
Israel,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced vital capacity -FVC | Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort | a month prior to surgery | No |
Primary | 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 | No |
Primary | Maximum voluntary ventilation-MVV | Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort | a month prior to surgery | No |
Primary | Functional residual capacity-FRC | Functional residual capacity: the volume in the lungs at the end-expiratory position | a month prior to surgery | No |
Primary | Residual volume -RV | Residual volume: the volume of air remaining in the lungs after a maximal exhalation. | a month prior to surgery. | No |
Primary | 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. | No |
Primary | 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. | No |
Primary | 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. | No |
Primary | Forced vital capacity -FVC | Forced vital capacity: the determination of the vital capacity from a maximally forced | a month after surgery | No |
Primary | Forced vital capacity -FVC | Forced vital capacity: the determination of the vital capacity from a maximally forced | three months after surgery | No |
Primary | 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 | No |
Primary | 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 | No |
Primary | Maximum voluntary ventilation-MVV | Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort | a month after surgery | No |
Primary | Maximum voluntary ventilation-MVV | Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort | three months after surgery | No |
Primary | Functional residual capacity-FRC | Functional residual capacity: the volume in the lungs at the end-expiratory position | a month after surgery | No |
Primary | Functional residual capacity-FRC | Functional residual capacity: the volume in the lungs at the end-expiratory position | three months after surgery | No |
Primary | Residual volume -RV | Residual volume: the volume of air remaining in the lungs after a maximal exhalation. | a month after surgery | No |
Primary | Residual volume -RV | Residual volume: the volume of air remaining in the lungs after a maximal exhalation. | three months after surgery | No |
Primary | 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. | No |
Primary | 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. | No |
Primary | 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 | No |
Primary | 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. | No |
Primary | 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. | No |
Primary | 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. | No |
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