Comparison Between Prepectoral and Subpectoral Breast Reconstruction (RESPECT)

The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy

There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction.

This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.

Study Overview

• Status: Recruiting
• Conditions: Stage I Breast Cancer; Stage II Breast Cancer
• Intervention / Treatment: Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy

Detailed Description

Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.

• Study Type: Observational
• Enrollment (Anticipated): 88

Contacts and Locations

• Study Contact: Name: guoxuan gao, MD; Phone Number: +861063138712; Email: aliceggx@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: guoxuan Guo; Phone Number: +861063138712; Email: aliceggx@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) and having willingness for breast reconstruction.

Description

Inclusion Criteria:

1. Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
2. Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
3. Patients having willingness for breast reconstruction.
4. Age between 18 to 70 years.
5. Maximum diameter of the cancer lesion ≤ 3 cm.
6. Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.
7. The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.

Exclusion Criteria:

1. patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
2. Having history of malignant tumor (s) within 5 years.
3. Patients under immunosuppressive therapy for organ transplantation.
4. Having continuous systemic steroid hormone therapy.
5. Pregnant or lactating women.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The prepectoral breast reconstruction; The patients received prepectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy	Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy; Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction
The subpectoral breast reconstruction; The patients received subpectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy	Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy; Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
breast satisfaction	measured by BREAST-Q score	12 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical well-being of chest	measured by BREAST-Q score	12 months after operation
Animation deformity	confirmed by the doctor's physical examination	12 months after operation
Adverse events	according to Clavien-Dindo system	within 30 days after surgery
Local recurrence and distant metastasis of breast cancer	physical examination or imaging examination with histologically confirmed	12 months after operation

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Beijing Health Promotion Association
• Investigators: Principal Investigator: guoxuan gao, MD, Department of General Surgery, Beijing Friendship Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2027

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; breast reconstruction; endoscopic nipple-sparing mastectomy; breast satisfaction; BREAST-Q score
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RESPECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No