Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- E-NSM Group
- description
- Patients who underwent single-port endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction.
- label
- C-NSM Group
- description
- Patients who underwent conventional nipple-sparing mastectomy with immediate implant-based breast reconstruction.
Primary outcomes (1)
- measure
- Patient-Reported Outcomes (PROs) as measured by BREAST-Q
- timeFrame
- 6 to 45 months postoperatively
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available