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Prepectoral and Subpectoral Implant-based Breast Reconstruction

NCT04688697 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-04-02

No results posted yet for this study

Summary

Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase year by year, while implant reconstruction has become the most important way of breast reconstruction due to its less injury, shorter time of operation and relatively simple surgical technique. In the long-term clinical practice, due to the lack of safe and effective alternative methods, the reconstruction method with prosthesis placed to posterior pectoralis major has been accepted by surgeons and patients, and has become the most commonly used method of prosthesis construction. However, the development of biomaterials provides new ideas for breast reconstruction. At present, more and more doctors in clinical practice discontinue the use of serratus anterior, but use the synthetic mesh (mostly titanium mesh TiLoop® Bra) or allogeneic acellular dermal matrix mesh to cover part of the dilator or prosthesis so as to shorten the entire operation cycle and make the appearance of the reconstructed breast more natural and aesthetic. In particular, it can improve the contour of the folds under the breast and shape the breasts with a certain degree of sagging.

This study takes the patients receiving immediate reconstruction with an implant combined with TiLoop® Bra after total mastectomy as the subjects, aiming to compare the aesthetics and safety of the placement of implant to anterior and posterior pectoralis major through a prospective and randomized study. The primary objective of the study is to analyze the aesthetics of breast appearance, patient satisfaction and postoperative quality of life (QOL) of the placement of implant to anterior and posterior pectoralis major. The secondary objective of the study is to analyze the incidence of complications and type of reoperation in both groups.

Conditions

  • Breast Carcinoma
  • Breast Reconstruction

Interventions

PROCEDURE

prepectoral implant-based reconstruction

In this group, patients receive breast reconstruction with prosthesis placed to anterior pectoralis major, synthetic mesh is used to enclose the prosthesis and place it to anterior pectoralis major.

PROCEDURE

subpectoral implant-based reconstruction

In this group, patients receive breast reconstruction with placed to posterior pectoralis major, part of the mesh is placed under the pectoralis major during the operation, and the mesh is used to cover the suture of the prosthesis on the inferior plica, or to directly enclose the lower part of the implant.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2024-12-27
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688697 on ClinicalTrials.gov