Comparison of Safety and Patients-Reported Outcomes Between Single-Port Endoscopic and Conventional Nipple-Sparing Mastectomy With Immediate Implant Reconstruction

Comparison of Safety and Patients-Reported Outcomes Between Single-Port Endoscopic and Conventional Nipple-Sparing Mastectomy With Immediate Implant Reconstruction: A Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Reconstruction

Detailed Description

1. 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.

   Exclusion Criteria: Patients undergoing delayed reconstruction, those with severe cardiopulmonary/psychiatric comorbidities, prior breast plastic surgery, active long-term smoking, inflammatory breast cancer, or uncontrolled diabetes.

5. Interventions & Grouping

   Participants were categorized based on the surgical technique received:

   E-NSM Group (n=342): Surgery performed via a single axillary incision (5-8 cm) using endoscopic visualization and techniques to create and work within a gas-dissected cavity.

   C-NSM Group (n=129): Surgery performed via traditional incisions (e.g., inframammary fold) under direct vision.

   All procedures were performed by experienced senior breast surgical oncologists following standardized institutional protocols. All patients received adjuvant therapies (chemotherapy, endocrine therapy, radiotherapy) per established clinical guidelines (e.g., NCCN).

6. Outcome Measures Primary Outcome (Safety): Incidence of postoperative complications, including flap ischemia/necrosis, nipple ischemia/necrosis, infection, seroma, implant removal, capsular contracture, and chronic pain.

   Secondary Outcomes:

   Oncological: Disease-free survival (DFS), local recurrence, and distant metastasis.

   Patient-Reported Outcomes: Scores from the BREAST-Q v2.0 questionnaire (domains: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being, Satisfaction with Care).

7. Data Collection & Follow-up Data were extracted retrospectively from electronic medical records. Follow-up was conducted every six months postoperatively via outpatient visits or telephone assessment. Data collected included demographics, clinicopathological features, surgical details, complications, oncological events, and BREAST-Q scores. Tumor markers and imaging (ultrasound, CT, bone scan) were used for recurrence surveillance.
8. Statistical Analysis Data analysis will be performed using SPSS software (v27.0). Continuous variables will be compared using independent t-tests and reported as mean ± standard deviation. Categorical variables will be compared using Chi-square or Fisher's exact tests, as appropriate. Disease-free survival will be analyzed using Kaplan-Meier curves and the Log-rank test. A two-sided p-value < 0.05 will be considered statistically significant.
9. Ethical & Regulatory Considerations The study protocol was reviewed and approved by the Medical Ethics Committee of the First Affiliated Hospital of the Air Force Medical University (Approval No.: KY20232134-F-1). As a retrospective analysis of anonymized clinical data, the requirement for individual patient informed consent was waived. This study is reported in accordance with the STROCSS guidelines and has been registered prospectively on a public clinical trials registry.

• Study Type: Observational
• Enrollment (Actual): 471

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • The First Affiliated Hospital of the Air Force Medical University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort study included adult female patients diagnosed with breast cancer who underwent nipple-sparing mastectomy (NSM) with immediate implant-based reconstruction at a single academic hospital between April 2021 and April 2024. Patients were categorized based on the surgical approach they received: endoscopic NSM (E-NSM) or conventional NSM (C-NSM).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes (PROs) as measured by BREAST-Q	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.	6 to 45 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Complications	The rate of surgical complications following mastectomy with reconstruction, including flap ischemia, flap necrosis, nipple ischemia, nipple necrosis, infection, seroma, implant removal, capsular contracture, and chronic pain. Complications will be graded according to the Clavien-Dindo classification.	up to 3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival (DFS)	Time from surgery to the first occurrence of local recurrence, distant metastasis, or death from any cause.	6 to 45 months postoperatively

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Juliang Zhang, MD, PhD, The First Affiliated Hospital of the Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): April 21, 2024
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Surgical Techniques; Breast reconstruction; BREAST-Q; Single-port endoscopic surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: KY20232134-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision regarding IPD sharing has not been finalized by the study team and the institution. Data sharing is contingent upon the development of a formal plan that ensures compliance with ethical regulations, protects participant privacy, and addresses institutional policies. Further details will be provided in the publication.

Drug and device information, study documents

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