NCT03319862

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 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

November 14, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2017

Completed
Last Updated

March 1, 2018

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

October 16, 2017

Last Update Submit

February 28, 2018

Conditions

Gynecomastia

Outcome Measures

Primary Outcomes (1)

  • aesthetic result score

    patient answer to a satisfaction questionnaire

    Average of 6 months post-surgery

Interventions

Inferior pédicule gynaecomastiaPROCEDURE

Inferior pédicule gynaecomastia

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • inferior pedicle gynaecomastia surgery
  • Age \> 16

You may not qualify if:

  • Age \< 16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Gynecomastia

Condition Hierarchy (Ancestors)

Breast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Philippe LEVAN, MD

    GHPSJ

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 24, 2017

Study Start

November 14, 2016

Primary Completion

September 30, 2017

Study Completion

November 2, 2017

Last Updated

March 1, 2018

Record last verified: 2017-10

Locations

FR(1)