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临床试验/NCT02491762
NCT02491762Unknown不适用

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

Yaron Har-Shai1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Residual volume -RV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

结局指标

主要结局

Residual volume -RV

时间窗: three months after surgery

Residual volume: the volume of air remaining in the lungs after a maximal exhalation.

Total lung capacity-TLC

时间窗: three months after surgery.

Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.

Forced vital capacity -FVC

时间窗: three months after surgery

Forced vital capacity: the determination of the vital capacity from a maximally forced

Forced expiratory volume at one second -FEV1

时间窗: three months after surgery

Volume that has been exhaled at the end of the first second of forced expiration

Functional residual capacity-FRC

时间窗: three months after surgery

Functional residual capacity: the volume in the lungs at the end-expiratory position

Maximal inspiratory pressure-MIP

时间窗: three months after 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-MEP

时间窗: three months after surgery.

Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.

Maximum voluntary ventilation-MVV

时间窗: three months after surgery

Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort

次要结局

未报告次要终点

研究者

发起方
Yaron Har-Shai
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yaron Har-Shai

Clinical Professor Yaron Har-Shai

Carmel Medical Center

研究点 (1)

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