Status:
COMPLETED
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Association la Montpellier Reine a du Cœur
Conditions:
Genetic Predisposition
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
NA
Brief Summary
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniq...
Detailed Description
It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy, using an axillary single port. Classic open surgery conversion rate, operative time, infectious rate, esthetica...
Eligibility Criteria
Inclusion
- Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
- Ask an immediate breast reconstruction during the surgery
- World Heath Organization score \<3
- Glandular volume : french bra cup size A, B ou C
- Glandular ptosis \<=2 (Classification and Algorithm for Treatment of Breast Ptosis)
- Contraception for woman of childbearing age and no pregnancy
- Valid Social Security
- Wrote consent
Exclusion
- History of breast cancer surgery
- Breast cancer not operated on the side concerned by the prophylactic mastectomy
- Patient having had irradiant treatment
- Breast hypertrophy
- Smoking \> 10 cigarette/day
- Body Mass Index \> 30
- Large breast volume requiring prostheses \> 500ml
- Chronic pulmonary obstructive gold 4
- ASA (Physical Status score of American Society of Anesthesiologists) \> 3
- Chronic shoulder pain on the side to operate, or both shoulders
- History of abarticular pathology of the shoulder on the operating side
- Patient involvment in another clinical research
- Protected patient or unable to give consent
- Pregnant or breastfeeding woman
- Vulnerable person (Article L1121-6 of the Public Health Code)
Key Trial Info
Start Date :
April 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03838549
Start Date
April 26 2019
End Date
September 26 2025
Last Update
December 16 2025
Active Locations (1)
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1
Montpellier University Hospital
Montpellier, Hérault, France, 34295