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

Sponsor
Chinese Academy of Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00505557
Collaborator
(none)
1
23

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transaxillary dual plane technique
Phase 1

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 Design

Study Type:
Interventional
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 1, 2008

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00505557
Other Study ID Numbers:
  • 621125-1
First Posted:
Jul 23, 2007
Last Update Posted:
Jun 24, 2009
Last Verified:
Jun 1, 2009

Study Results

No Results Posted as of Jun 24, 2009