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

Phase 1

Completed

• Conditions: Mammoplasty

• Registration Number: NCT00505557
• Lead Sponsor: Chinese Academy of Sciences

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 Timeline

• Study Start: 2006-05
• Primary Completion: 2007-04
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Study Completion: 2008-04
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage.	within half year after surgery

Trial Locations

Locations (1)

Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Sciences & Peking Union Medical College; 🇨🇳 Beijing, China