Comparison of Safety and Patients-Reported Outcomes Between Single-Port Endoscopic and Conventional Nipple-Sparing Mastectomy With Immediate Implant Reconstruction: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes (PROs) as measured by BREAST-Q
研究概览
简要总结
Why is this study being done? Breast cancer is very common among women. Today, patients not only seek effective treatment but also care about their quality of life after surgery, including how they feel and how satisfied they are with the results. Doctors have developed different surgical methods. One newer method uses a tiny camera (called an endoscope) to perform the surgery through small openings, while the traditional method uses a larger incision. The newer method may lead to better cosmetic results and faster recovery, but its overall safety and impact on patients' daily life and well-being still need more evidence from research. This study aims to thoroughly compare these two surgical approaches to help doctors and patients make better-informed decisions.
What will happen in this study? This is a review study. We will look back at the medical records of about 471 women who underwent breast surgery with immediate reconstruction at our hospital between April 2021 and April 2024. Among them, about 342 patients had the newer endoscopic surgery, and 129 had the traditional surgery. We will compare information already in their records about surgery complications, cancer outcomes, and their answers to a quality-of-life questionnaire (called BREAST-Q).
Who can be in this study? The study includes adult women who had the specific types of breast surgery mentioned above at our hospital during that time.
What does this mean for patients? Because this study only reviews past medical records, no new actions or tests are required from any patients. We are only analyzing information that already exists. The results of this study may help future patients understand the potential benefits and risks of each surgical option, supporting more personalized and evidence-based healthcare choices.
详细描述
- Study Objectives Primary Objective: To compare the surgical safety of endoscopic nipple-sparing mastectomy (E-NSM) versus conventional nipple-sparing mastectomy (C-NSM) with immediate implant-based reconstruction, as measured by postoperative complication rates.
Secondary Objectives:
To compare oncological safety between the two groups, assessed by disease-free survival (DFS).
To compare patient-reported outcomes (PROs) between the two groups using the validated BREAST-Q version 2.0 questionnaire. 2. Background & Rationale Breast cancer remains a leading cause of cancer-related morbidity in women. Alongside oncological efficacy, patient satisfaction and health-related quality of life (HRQoL) have become critical endpoints in evaluating breast reconstruction outcomes. Nipple-sparing mastectomy (NSM) is favored for its superior cosmetic results. However, conventional NSM (C-NSM) requires a relatively large incision, which may impair blood supply to the nipple-areola complex (NAC), increasing the risk of necrosis.
Minimally invasive techniques like endoscopic NSM (E-NSM) offer potential advantages, including smaller incisions and possibly better preservation of tissue perfusion. While E-NSM adoption is growing, robust comparative evidence on its safety profile and impact on patient-reported outcomes versus the established C-NSM is limited. Existing studies are often constrained by small sample sizes or the use of non-standardized PRO measures. This retrospective cohort study aims to provide a comprehensive comparative analysis to strengthen the evidence base for clinical decision-making regarding these two surgical approaches. 3. Study Design This is a single-center, retrospective, observational cohort study conducted at The First Affiliated Hospital of the Air Force Medical University, a tertiary academic institution. 4. Participant Selection Study Period: April 2021 to April 2024. Inclusion Criteria: Female patients aged 18-65 years who underwent immediate implant-based breast reconstruction following NSM. This includes patients with preoperative pathological confirmation of breast malignancy (including prophylactic mastectomy for high-risk lesions/BRCA mutations) and confirmed absence of skin/NAC involvement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-65 years
- •Preoperative pathological confirmation of breast malignancy via core needle biopsy (including phyllodes tumors, borderline lesions, or BRCA gene mutations undergoing prophylactic mastectomy)
- •Imaging or intraoperative examination confirming no invasion of the tumor into the skin, subcutaneous tissue, or chest wall
- •Contraindications to breast-conserving surgery or patient-initiated choice to undergo total mastectomy with immediate reconstruction
排除标准
- •Patients undergoing delayed breast reconstruction
- •Severe cardiopulmonary dysfunction or psychiatric disorders
- •History of breast plastic surgery
- •Long-term smokers
- •Inflammatory breast cancer
- •Diabetic patients with poorly controlled blood glucose
研究组 & 干预措施
E-NSM Group
Patients who underwent single-port endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction.
C-NSM Group
Patients who underwent conventional nipple-sparing mastectomy with immediate implant-based breast reconstruction.
结局指标
主要结局
Patient-Reported Outcomes (PROs) as measured by BREAST-Q
时间窗: 6 to 45 months postoperatively
Scores from the BREAST-Q version 2.0 questionnaire, including domains: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being (Chest, Back \& Shoulder), and Satisfaction with Care (Surgeon, Information). Higher scores indicate greater satisfaction or better quality of life.
次要结局
- Incidence of Postoperative Complications(up to 3 months postoperatively)
研究者
Zhang Juliang-1
Associate Professor and Deputy Chief Physician
Xijing Hospital