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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02491762
• Other study ID #: CMC-15-0029-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 16, 2015
• Last updated: July 13, 2015
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: July 2015
• Source: Carmel Medical Center
• Contact: Yaron Har-Shai, Proffesor
• Phone: 0507866206
• Email: yaron07[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Reconstruction
• Respiratory Function

Intervention

Procedure:
• respiratory function tests
FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Yaron Har-Shai

Country where clinical trial is conducted

Israel, 

References & Publications (22)

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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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

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