Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
- Conditions
- Breast Reduction
- Interventions
- Device: Reduction of breast hypertrophy by means of laparoscopic
- Registration Number
- NCT05822115
- Lead Sponsor
- Groupe Hospitalier Nord-Essonne
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treated group Reduction of breast hypertrophy by means of laparoscopic Breast reduction
- Primary Outcome Measures
Name Time Method Photography of the scar at 3 months centimeter
- Secondary Outcome Measures
Name Time Method Blood loss at 1 day the haemoglobin (hb) level
Scar assessment at 3 weeks number of scars
Photography of Areola at 3 weeks, 3 months and 1 year Centimeter
Resection weight at 0 day Resection weight
Scar lenght at 3 weeks, 3 months and 1 year Centimeter
Cancer at day 0 presence or absence
Macroeconomic impact at 1 year length of hospital stay, duration of surgery
Pain scale at 3 weeks, 3 months and 1 year 0 (no pain) to 10 (very intense pain)
Satisfaction scale at 3 weeks, 3 months and 1 year 0 (dissatisfied) to 10 (satisfied)
Scar thickness at 3 weeks, 3 months and 1 year Centimeter
Trial Locations
- Locations (1)
Dr Eric DUNET
🇫🇷Longjumeau, France