NCT02769559

Brief Summary

The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

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

January 1, 2000

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

14.9 years

First QC Date

May 10, 2016

Last Update Submit

May 11, 2016

Conditions

MacromastiaSigns and SymptomsQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Questionnaires about quality of life before and up to 12 years after surgery

    2000-2014

Secondary Outcomes (1)

  • Rate of adverse outcomes

    2000-2014

Study Arms (1)

Patients with macromasty

Female adult patients with symptomatic macromasty selected for elective reduction surgery

Procedure: Reduction mammaplasty

Interventions

Reduction mammaplastyPROCEDURE

Surgical removal of excess breast tissue

Patients with macromasty

Eligibility Criteria

Age18 Years - 63 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Females with macromastia undergoing elective reduction surgery.

You may qualify if:

  • above 18 years
  • macromastia on clinical examination
  • fulfilled Breast Q Questionnaire prior to surgery and after surgery
  • signed informed consent

You may not qualify if:

  • failed to sign informed consent
  • failed to fill the Breast Q Questionnaire
  • patients with altered mental status and behaviour
  • patients with concomitant breast disease, or with previous breast interventions as are radiotherapy, surgery, or breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bratislava

Bratislava, 82101, Slovakia

Location

MeSH Terms

Conditions

GigantomastiaSigns and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reduction mammaplasty safely increases the quality of life in patients with mammary hypetrophy.

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 11, 2016

Study Start

January 1, 2000

Primary Completion

December 1, 2014

Study Completion

May 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)