Back to resultsReduction of Breast Hypertrophy by Means of Coelioscopique Surgery (R-HTM-R)
Primary Purpose
Breast Reduction
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Reduction of breast hypertrophy by means of laparoscopic
Sponsored by
About this trial
This is an interventional other trial for Breast Reduction
Eligibility Criteria
Inclusion criteria : 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. Non inclusion criteria : 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. Patient participating in another clinical study. Protected patient: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision. Pregnant, lactating woman.
Sites / Locations
- Dr Eric DUNETRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treated group
Arm Description
Breast reduction
Outcomes
Primary Outcome Measures
Photography of the scar
centimeter
Secondary Outcome Measures
Scar assessment
number of scars
Resection weight
Resection weight
Photography of Areola
Centimeter
Scar lenght
Centimeter
Blood loss
the haemoglobin (hb) level
Pain scale
0 (no pain) to 10 (very intense pain)
Satisfaction scale
0 (dissatisfied) to 10 (satisfied)
Cancer
presence or absence
Macroeconomic impact
length of hospital stay, duration of surgery
Scar thickness
Centimeter
Full Information
NCT ID
NCT05822115
First Posted
March 21, 2023
Last Updated
May 5, 2023
Sponsor
Groupe Hospitalier Nord-Essonne
1. Study Identification
Unique Protocol Identification Number
NCT05822115
Brief Title
Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
Acronym
R-HTM-R
Official Title
Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier Nord-Essonne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Breast reductions are common procedures. One of the main difficulties related to this surgery remains the healing, wide at the peri-areolar level, vertical at the sub-areolar level and in the sub-mammary fold. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloidal healing, especially in young subjects.
On This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result without scarring in the context of the reduction of medium volume breast hypertrophy.
Ultimately, the results of this study may serve as a basis for further research by proposing:
Prophylactic mastectomies and immediate breast reconstruction without lateral scar and with a less visible sub-breast scar.
A breast reduction in young patients before the skin undergoes the effects of the heaviness of the breasts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Reduction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treated group
Arm Type
Experimental
Arm Description
Breast reduction
Intervention Type
Device
Intervention Name(s)
Reduction of breast hypertrophy by means of laparoscopic
Other Intervention Name(s)
R-HTM-R
Intervention Description
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.
Primary Outcome Measure Information:
Title
Photography of the scar
Description
centimeter
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Scar assessment
Description
number of scars
Time Frame
at 3 weeks
Title
Resection weight
Description
Resection weight
Time Frame
at 0 day
Title
Photography of Areola
Description
Centimeter
Time Frame
at 3 weeks, 3 months and 1 year
Title
Scar lenght
Description
Centimeter
Time Frame
at 3 weeks, 3 months and 1 year
Title
Blood loss
Description
the haemoglobin (hb) level
Time Frame
at 1 day
Title
Pain scale
Description
0 (no pain) to 10 (very intense pain)
Time Frame
at 3 weeks, 3 months and 1 year
Title
Satisfaction scale
Description
0 (dissatisfied) to 10 (satisfied)
Time Frame
at 3 weeks, 3 months and 1 year
Title
Cancer
Description
presence or absence
Time Frame
at day 0
Title
Macroeconomic impact
Description
length of hospital stay, duration of surgery
Time Frame
at 1 year
Title
Scar thickness
Description
Centimeter
Time Frame
at 3 weeks, 3 months and 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria :
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.
Non inclusion criteria :
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.
Patient participating in another clinical study.
Protected patient: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Pregnant, lactating woman.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Dr DUNET, Chirurgien
Phone
+33607812501
Email
ericdunet@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme Mr KOZLOWSKI, Directeur Innovation Recherche
Phone
+33664542963
Email
n.goumas@ghne.fr
Facility Information:
Facility Name
Dr Eric DUNET
City
Longjumeau
ZIP/Postal Code
91160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Eric Dunet Principal investigator
Phone
ericdunet@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
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