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Completed

NCT Number: NCT00505557

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

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.

Completed

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, 100041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transaxillary dual plane technique

Procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jul 23, 2007
Registry last updated
Jun 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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