NCT07037537

Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation of Nipple and Areola, Immediate One-step Breast Reconstruction With Pectoral Muscle Prosthesis and Patch, and Simultaneous Autologous Fat Transplantation

To Evaluate the Efficacy and Safety of Laparoscopic-assisted Nipple-areola-sparing Mastectomy Plus Pectoral Anterior Prosthesis Plus Mesh Immediate One-step Breast Reconstruction Plus Concurrent Autologous Fat Grafting: a Prospective, Single-centre, Single-arm Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study

Detailed description

This study is a prospective, single center, single arm clinical trial. It is planned to recruit 29 patients with unilateral breast cancer of cT1-2N0M0. Patients who meet the inclusion criteria are planned to undergo laparoscopic assisted NSM+prosthesis combined with patch breast reconstruction and concurrent fat transplantation surgery. Main endpoint of the study: incidence of severe complications after breast reconstruction surgery. Secondary study endpoints: BREAST-Q (Breast Reconstruction Module) score, breast reconstruction success rate, incidence of all complications, physician evaluated breast cosmetic outcomes, occurrence of capsule contractures, nipple areola and breast skin sensation, and tumor safety.

Conditions

• Breast Cancer Patients

Interventions

Type	Name	Description
PROCEDURE	Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation	Laparoscopic assisted mastectomy with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch, immediate one-step breast reconstruction and simultaneous autologous fat transplantation

Timeline

• Start date: 2024-10-30
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: China