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Procedure

Prepectoral Group for Breast Reconstruction

N/A
Waitlist Available
Research Sponsored by Fudan University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 18 months after the operation
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Breast Cancer
  • Breast Reconstruction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months after the operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months after the operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patients' satisfaction
Secondary study objectives
Incidences of complications and serious complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prepectoral GroupExperimental Treatment1 Intervention
Prepectoral implant-based reconstruction applied for patients in this group
Group II: Subpectoral GroupActive Control1 Intervention
Subpectoral implant-based reconstruction applied for patients in this group

Find a Location

Who is running the clinical trial?

Fudan UniversityLead Sponsor
1,231 Previous Clinical Trials
1,677,360 Total Patients Enrolled
1 Trials studying Breast Reconstruction
10,000 Patients Enrolled for Breast Reconstruction
~61 spots leftby Dec 2025