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

NCT07410728 | Completed

• 1 other identifier: KY20232134-F-1
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Breast Reconstruction

Keywords

Single-port endoscopic surgery; Breast reconstruction; BREAST-Q; Surgical Techniques

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Postoperative Complications

  up to 3 months postoperatively

Other Outcomes (1)

• Disease-Free Survival (DFS)

  6 to 45 months postoperatively

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital of the Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Juliang Zhang, MD, PhD

  The First Affiliated Hospital of the Air Force Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Deputy Chief Physician

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 13, 2026
• Study Start: April 21, 2021
• Primary Completion: April 21, 2024
• Study Completion: July 8, 2024
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (1)