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

This study has been completed.
Sponsor:
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT00505557
First received: July 20, 2007
Last updated: June 23, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Mammoplasty
 Procedure: Transaxillary dual plane technique
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • 98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage. [ Time Frame: within half year after surgery ] [ Designated as safety issue: Yes ]

Study Start Date: May 2006
Study Completion Date: April 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505557

Locations
China
Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, China, 100041
Sponsors and Collaborators
Chinese Academy of Sciences
Investigators
Study Chair: Yilin Cao, M.D. Chinese Academy of Medical Sciences
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00505557     History of Changes
Other Study ID Numbers: 621125-1
Study First Received: July 20, 2007
Last Updated: June 23, 2009
Health Authority: China: Ministry of Health

Keywords provided by Chinese Academy of Sciences:
augmentation mammoplasty
Dual plane
Endoscope
Transaxillary incision

ClinicalTrials.gov processed this record on May 16, 2013