Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction
Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT03319862
Collaborator
(none)
28
1
11.6
2.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
28 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction
Actual Study Start Date
:
Nov 14, 2016
Actual Primary Completion Date
:
Sep 30, 2017
Actual Study Completion Date
:
Nov 2, 2017
Outcome Measures
Primary Outcome Measures
- aesthetic result score [Average of 6 months post-surgery]
patient answer to a satisfaction questionnaire
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
inferior pedicle gynaecomastia surgery
-
Age > 16
Exclusion Criteria:
- Age < 16
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France | France | 75014 |
Sponsors and Collaborators
- Groupe Hospitalier Paris Saint Joseph
Investigators
- Study Director: Philippe LEVAN, MD, GHPSJ
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT03319862
Other Study ID Numbers:
- PEDINF
First Posted:
Oct 24, 2017
Last Update Posted:
Mar 1, 2018
Last Verified:
Oct 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: