Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00505557
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : June 24, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Mammoplasty 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : May 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505557


Locations
Layout table for location information
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
Layout table for investigator information
Study Chair: Yilin Cao, M.D. Chinese Academy of Medical Sciences
Publications:
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00505557    
Other Study ID Numbers: 621125-1
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009
Keywords provided by Chinese Academy of Sciences:
augmentation mammoplasty
Dual plane
Endoscope
Transaxillary incision