Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction

February 28, 2018 updated by: Groupe Hospitalier Paris Saint Joseph
The massive weight loss leads an important excess of skin on thoracic level giving the aspect of a feminine breast with a relatively important ptose. Several techniques were described in the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not handled yet enough. Moreover, there is no single consensual technique on this subject. The technique used in this service was described for the first time in 2008 ( 1 ) on a serie of 8 patients with an average follow-up of 13 months. Although the results are promising, no other publication was done, and the procedure remains badly represented in the world literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

every patient hospitalized for gynaecomastia but only whose have a inferior pedicle gynaecomastia are selected for the project.

Description

Inclusion Criteria:

  • inferior pedicle gynaecomastia surgery
  • Age > 16

Exclusion Criteria:

  • Age < 16

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aesthetic result score
Time Frame: Average of 6 months post-surgery
patient answer to a satisfaction questionnaire
Average of 6 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Study Director: Philippe LEVAN, MD, GHPSJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 14, 2016

Primary Completion (ACTUAL)

September 30, 2017

Study Completion (ACTUAL)

November 2, 2017

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (ACTUAL)

October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEDINF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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