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临床试验/NCT00505557
NCT00505557已完成1 期

Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope

Chinese Academy of Sciences2 个研究点 分布在 1 个国家开始时间: 2006年5月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
试验地点
2
主要终点
98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage.

研究概览

简要总结

The purpose of this study is to evaluate the feasibility and outcome of performing dual plane breast augmentation with assistant of endoscope by axillary approach.

详细描述

Dual plane augmentation mammoplasty is a logical approach to realize the benefits of retromammary and partial retropectoral implant placement while minimizing the tradeoffs of other pocket locations. Traditionally, dual plane augmentation has been performed using transareolar or inframammary fold approach. However, the approach is unacceptable to Chinese patients because of the front scar formation. For aesthetic reasons, the axillary incision is more acceptable approach for augmentation mammoplasty.

The endoscope assistant technique has been widely used in transaxillary breast augmentation. It provides the feasibility to perform dual plane breast augmentation by axillary approach.

In this research, at least 40 patients with light degree of glandular ptotic and constricted lower pole breasts are selected to receive soft cohesive gel microtextured anatomic style silicone implants. Portions of the pectoralis major muscle is split without its release from the costal margin with the help of a 10mm, 30°endoscope and endoscopic diathermy scissors through a 4-cm incision in the axilla each side. Bleeding during surgery is kept to the minimum. The results of outcomes, operative time, bleeding volume, drainage volume, complications are observed.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All women who want breast augmentation using the implants.Especially for the patients with
  • glandular ptotic (< I degree) breasts
  • thick soft tissues (> 10 mm) in the low pole of the breast

排除标准

  • With thin soft tissues (< 9 mm) in the low pole of the breast

结局指标

主要结局

98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage.

时间窗: within half year after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (2)

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