RecruitingNCT05833659

Comparison Between Prepectoral and Subpectoral Breast Reconstruction

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


Sponsor

Beijing Friendship Hospital

Enrollment

88 participants

Start Date

Mar 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two techniques for breast reconstruction after mastectomy (removal of the breast) in women with early-stage breast cancer: placing the implant in front of the chest muscle (prepectoral) versus behind the chest muscle (subpectoral). Both approaches are already used in practice; this study aims to find out which one leads to better outcomes and quality of life. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with early-stage breast cancer (stage I or II) confirmed by biopsy - Breast-conserving surgery is not suitable for you, or you prefer a full mastectomy - You want breast reconstruction after mastectomy - The tumor is 3 cm or smaller and has not spread to the skin or chest wall **You may NOT be eligible if...** - You have had a serious heart event (heart attack or stroke) in the past 6 months - You have had another cancer in the past 5 years - You are on immunosuppressive drugs (e.g., after an organ transplant) or long-term steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREThe breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy

Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction


Locations(1)

Beijing Friendship Hospital, Capital medical University

Beijing, Beijing Municipality, China

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NCT05833659


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