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

NCT ID: NCT00505557

Last Updated: 2009-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Mammoplasty

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Transaxillary dual plane technique

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Yilin Cao, M.D.

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences

Locations

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

Beijing, , China

Site Status

Countries

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China

References

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Yu L, Wang J, Zhang B, Zhu C. Endoscopic transaxillary capsulectomy. Aesthetic Plast Surg. 2006 May-Jun;30(3):282-5. doi: 10.1007/s00266-005-0159-0.

Reference Type BACKGROUND
PMID: 16733771 (View on PubMed)

Villafane O, Garcia-Tutor E, Taggart I. Endoscopic transaxillary subglandular breast augmentation using silicone gel textured implants. Aesthetic Plast Surg. 2000 May-Jun;24(3):212-5. doi: 10.1007/s002660010035.

Reference Type BACKGROUND
PMID: 10890950 (View on PubMed)

Howard PS. The role of endoscopy and implant texture in transaxillary submuscular breast augmentation. Ann Plast Surg. 1999 Mar;42(3):245-8. doi: 10.1097/00000637-199903000-00003.

Reference Type BACKGROUND
PMID: 10096613 (View on PubMed)

Howard PS, Oslin BD, Moore JR. Endoscopic transaxillary submuscular augmentation mammaplasty with textured saline breast implants. Ann Plast Surg. 1996 Jul;37(1):12-7. doi: 10.1097/00000637-199607000-00002.

Reference Type BACKGROUND
PMID: 8826586 (View on PubMed)

Tebbetts JB. Dual plane breast augmentation: optimizing implant-soft-tissue relationships in a wide range of breast types. Plast Reconstr Surg. 2006 Dec;118(7 Suppl):81S-98S; discussion 99S-102S. doi: 10.1097/00006534-200612001-00012.

Reference Type BACKGROUND
PMID: 17099485 (View on PubMed)

Tebbetts JB. Axillary endoscopic breast augmentation: processes derived from a 28-year experience to optimize outcomes. Plast Reconstr Surg. 2006 Dec;118(7 Suppl):53S-80S. doi: 10.1097/01.prs.0000247314.92351.99.

Reference Type BACKGROUND
PMID: 17099484 (View on PubMed)

Tofield JJ. Dual plane breast augmentation. Plast Reconstr Surg. 2001 Dec;108(7):2162-4. doi: 10.1097/00006534-200112000-00069. No abstract available.

Reference Type BACKGROUND
PMID: 11743433 (View on PubMed)

Tebbetts JB. Dual plane breast augmentation: optimizing implant-soft-tissue relationships in a wide range of breast types. Plast Reconstr Surg. 2001 Apr 15;107(5):1255-72. doi: 10.1097/00006534-200104150-00027.

Reference Type BACKGROUND
PMID: 11373572 (View on PubMed)

Other Identifiers

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621125-1

Identifier Type: -

Identifier Source: org_study_id

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