NCT03838549

Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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 techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

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, esthetical outcomes, and functional outcomes will be evaluated.

Conditions

• Genetic Predisposition
• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Prophylactic mastectomy with immediate breast reconstruction	It is an endoscopic approach for prophylactic mastectomy using an axillary single port

Timeline

• Start date: 2019-04-26
• Primary completion: 2025-09-26
• Completion: 2025-09-26
• First posted: 2019-02-12
• Last updated: 2025-12-16

Locations

1 site across 1 country: France