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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 20, 2007

Last Updated Date

July 23, 2007

Start Date ^†

May 2006

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00505557 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

Brief Summary

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.

Detailed Description

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Single Blind, Parallel Assignment

Condition ^†

Mammoplasty

Intervention ^†

Procedure: Transaxillary dual plane technique

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

With glandular ptotic (< I degree) breasts or with thick soft tissues (> 10 mm) of the breast

Exclusion Criteria:

With thin soft tissues (< 9 mm) of the breast

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

China

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00505557

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Chinese Academy of Sciences

Collaborators ^††

Investigators ^†

Study Chair:

Yilin Cao, M.D.

Chinese Academy of Medical Sciences

Information Provided By

Chinese Academy of Sciences

Verification Date

July 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.