NCT01297621

Brief Summary

This prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 9, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

February 16, 2011

Last Update Submit

July 5, 2013

Conditions

Breast Hypertrophy

Keywords

breast hypertrophyphysical activitysexualitypatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • physical activity

    Physical activity will be assessed by a validated instrument, the International Physical Activity Questionnaire (IPAQ), at pre-operative and 6 months after breast reduction

    6 months

Secondary Outcomes (2)

  • Patient's satisfaction

    6 months

  • Sexuality

    6 months

Study Arms (2)

Breast reduction

EXPERIMENTAL

Breast hypertrophy women allocated to this arm will undergo reduction mammaplasty

Procedure: reduction mammaplasty

Control

OTHER

Patients in this arm will be assessed twice, without surgical intervention

Other: control

Interventions

reduction mammaplastyPROCEDURE

conventional reduction mammaplasty

Breast reduction
controlOTHER

follow up, questionnaire responses

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • breast hypertrophy
  • candidate to reduction mammaplasty
  • body mass index under 30Kg/m2
  • women with sexual activity

You may not qualify if:

  • pregnancy, delivery or breast feeding during the last 12 months
  • body mass index over 30Kg/m2
  • breast cancer history
  • previous breast surgery
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

MeSH Terms

Conditions

GigantomastiaMotor ActivitySexualityPatient Satisfaction

Condition Hierarchy (Ancestors)

BehaviorSexual BehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Vanessa L Resende, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Miguel Sabino-Neto, MD, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

  • Daniela F Veiga, MD, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

  • Lydia M Ferreira, MD, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 17, 2011

Study Start

May 1, 2010

Primary Completion

February 1, 2013

Study Completion

June 1, 2013

Last Updated

July 9, 2013

Record last verified: 2013-07

Locations

BR(1)