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

Gynecomastia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319862
• Other study ID #: PEDINF
• Status: Completed
• Phase: N/A
• First received: October 16, 2017
• Last updated: February 28, 2018
• Start date: November 14, 2016
• Est. completion date: November 2, 2017

Study information

• Verified date: October 2017
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2, 2017
• Est. primary completion date: September 30, 2017
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• inferior pedicle gynaecomastia surgery

• Age > 16

Exclusion Criteria:

• Age < 16

Related Conditions & MeSH terms

• Gynecomastia
• Weight Loss

Intervention

Procedure:
• Inferior pédicule gynaecomastia
Inferior pédicule gynaecomastia

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aesthetic result score	patient answer to a satisfaction questionnaire	Average of 6 months post-surgery