Trial Outcomes & Findings for Asian Outcomes of Primary Breast Augmentation (NCT NCT02235285)

Results Overview

The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

162 participants

Primary outcome timeframe

5 years

Results posted on

2018-05-04

Participant Flow

Retrospective analysis was performed on 162 patients undergoing primary breast augmentation by a single surgeon during a 5-year period from 2010 to 2015.

This study presents data for 162 primary breast augmentation in either alone (n=152; 93.82 percent) or in conjunction with mastopexy (n=9; 5.56 percent) and inverted nipple correction (n=1; 0.62 percent) .

Participant milestones

Participant milestones
Measure	Breast Augmentation,Reoperation The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent.
Overall Study STARTED	162
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Asian Outcomes of Primary Breast Augmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=162 Participants Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	162 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	33.98 years STANDARD_DEVIATION 8.7 • n=93 Participants
Sex: Female, Male Female	162 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment Korea, Republic of	162 participants n=93 Participants

PRIMARY outcome

Timeframe: 5 years

The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.

Outcome measures

Outcome measures
Measure	Breast Augmentation, Reoperation n=162 Participants The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
Post Surgical Complications and Reoperation Rate During Breast Augmentation complications	1.85 percentage of participants Standard Deviation 0.05
Post Surgical Complications and Reoperation Rate During Breast Augmentation reoperation rate	1.85 percentage of participants Standard Deviation 0.05

Adverse Events

Breast Augmentation, Reoperation

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Breast Augmentation, Reoperation n=162 participants at risk The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
Skin and subcutaneous tissue disorders Capsular contracture	1.2% 2/162 • 5 years
Skin and subcutaneous tissue disorders Rippling	0.62% 1/162 • 5 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cheol Hwan Kim

The Department of Plastic Surgery, Winners Clinic

Phone: .+82.2.511.9446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place