Prepectoral and Subpectoral Implant-based Breast Reconstruction

NCT04688697 | Active Not Recruiting

• 1 other identifier: PSIBBR
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast carcinoma; breast reconstruction; Prepectoral prosthetic breast reconstruction; Complication

Outcome Measures

Primary Outcomes (1)

• Patients' satisfaction

  Patients' satisfaction evaluated based on Breast-Q scale

  18 months after the operation

Secondary Outcomes (1)

• Incidences of complications and serious complications

  During 18 months after the operation

Study Arms (2)

Prepectoral Group

EXPERIMENTAL

Prepectoral implant-based reconstruction applied for patients in this group

Procedure: prepectoral implant-based reconstruction

Subpectoral Group

ACTIVE COMPARATOR

Subpectoral implant-based reconstruction applied for patients in this group

Procedure: subpectoral implant-based reconstruction

Interventions

prepectoral implant-based reconstruction PROCEDURE

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.

Prepectoral Group

subpectoral implant-based reconstruction PROCEDURE

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.

Subpectoral Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 18 years old
• Female
• Preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ
• Clinical T1 and T2 (Maximum tumor diameter ≤5 cm)
• Clinical ALN negative (Clinical physical examination and ultrasound indicate axillary lymph node negative; Suspected abnormality of axillary lymph node, and fine needle aspiration negative)
• No clinical or imaging evidence of distant metastasis
• Patients to receive skin sparing mastectomy or nipple sparing mastectomy
• BMI \< 35
• Patients with no or mild mastoptosis
• Prosthesis to be implanted \<500 ml
• Be able and willing to sign the Informed Consent Form (ICF)

You may not qualify if:

• Patients with the breast of moderate-severe mastoptosis, or requiring the use of Wise-pattern or other breast lift methods for subcutaneous mammary gland resection
• BMI\>=35
• Patients who have received symmetrical breast surgery on the unaffected side immediately or later
• Patients with locally advanced breast cancer to receive neoadjuvant therapy
• Patients currently participating in other clinical trials, which may have impact on the participation in this trial
• Neoadjuvant therapy has been completed, and there is clear indication of adjuvant radiotherapy after the operation
• Previous history of breast cancer (patients with ipsilateral recurrence after breast sparing surgery)
• Pregnancy breast-feeding women
• History of smoking
• Previous history of diabetes

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vise President

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 30, 2020
• Study Start: May 12, 2021
• Primary Completion: December 27, 2024
• Study Completion: December 31, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CN (1)