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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02491762
Enrollment
45
Registered
2015-07-08
Start date
2015-08-31
Completion date
2017-08-31
Last updated
2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction, Respiratory Function

Keywords

Serratus Anterior, Accessory Respiratory, Tissue Expander, Respiratory Function Tests

Brief summary

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

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.

Interventions

PROCEDURErespiratory function tests

FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP

Sponsors

Yaron Har-Shai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Forced vital capacity -FVCa month prior to surgeryForced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
Forced expiratory volume at one second -FEV1a month prior to surgeryVolume that has been exhaled at the end of the first second of forced expiration
Maximum voluntary ventilation-MVVa month prior to surgeryMaximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort
Functional residual capacity-FRCa month prior to surgeryFunctional residual capacity: the volume in the lungs at the end-expiratory position
Residual volume -RVa month prior to surgery.Residual volume: the volume of air remaining in the lungs after a maximal exhalation.
Total lung capacity-TLCa month prior to surgery.Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.
Maximal inspiratory pressure-MIPa month prior to surgery.Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece
Maximal expiratory pressure-MEPa month prior to surgery.Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.

Countries

Israel

Contacts

Primary ContactYaron Har-Shai, Proffesor
yaron07@yahoo.com0507866206
Backup ContactRaviv Allon
ravivallon@gmail.com0523460305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026