Prepectoral and Subpectoral Implant-based Breast Reconstruction

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentric, Open-labeled, Prospective, Randomized Controlled Study to Compare the Satisfaction and Safety of the Prepectoral and Subpectoral Implant-based Breast Reconstruction in Patients Receiving Immediate Breast Reconstruction Using Implant Combined With TiLoop® Bra After Skin Sparing or Nipple-areola Sparing Mastectomy

Conditions
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Breast Carcinoma, Breast Reconstruction

Intervention / Treatment
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* Procedure: prepectoral implant-based reconstruction
* Procedure: subpectoral implant-based reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prepectoral Group<br>Prepectoral implant-based reconstruction applied for patients in this group | Procedure: prepectoral implant-based reconstruction<br>* 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.<br>|
| Active Comparator: Subpectoral Group<br>Subpectoral implant-based reconstruction applied for patients in this group | Procedure: subpectoral implant-based reconstruction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction | Patients' satisfaction evaluated based on Breast-Q scale | 18 months after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of complications and serious complications | Incidences of complications and serious complications | During 18 months after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast carcinoma, breast reconstruction, Prepectoral prosthetic breast reconstruction, Complication