Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
R-HTM-R
1 other identifier
interventional
5
1 country
1
Brief Summary
The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy. This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
April 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedMay 9, 2023
March 1, 2023
1.4 years
March 21, 2023
May 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Photography of the scar
centimeter
at 3 months
Secondary Outcomes (10)
Scar assessment
at 3 weeks
Resection weight
at 0 day
Photography of Areola
at 3 weeks, 3 months and 1 year
Scar lenght
at 3 weeks, 3 months and 1 year
Blood loss
at 1 day
- +5 more secondary outcomes
Study Arms (1)
treated group
EXPERIMENTALBreast reduction
Interventions
The research procedure is a breast reduction performed by means of laparoscopic surgery. The project consists of removing a disc from the breast at the level of the base, thus causing peripheral skin slackening of 2 to 3 cm but circular. Both breasts are usually operated on at the same time. In case of asymmetry, only one side will be treated.
Eligibility Criteria
You may qualify if:
- Women over the age of 18.
- Category 1 or 2 according to the Regnault classification.
- C cup breast size or larger.
- Areola "looks ahead" i.e. a distance between point A (at the top of the areola) at the median suprasternal point of approximately 16 cm to 24 cm.
- Ptosis (distance between the lowest part of the breast and the submammary fold) of a maximum of 7cm (measured in a seated position).
- Expected correction of half ptosis with decrease of 1 to 3 cup sizes.
- Patient has good quality thick skin.
- Social security scheme.
- Patient requesting breast reduction.
- Patient having signed the free and informed consent.
- Areola "look down"; point A more than 25 cm.
- Ptosis greater than or equal to 8 cm.
- Thin skin.
- Smoker.
- Patient under effects of anti-coagulant.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Eric DUNET
Longjumeau, 91160, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2023
First Posted
April 20, 2023
Study Start
April 24, 2023
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
May 9, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share