CompletedNot Applicable

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

China471 participantsStarted 2021-04-21

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient-Reported Outcomes (PROs) as measured by BREAST-Q

Timeframe: 6 to 45 months postoperatively

Trial details

NCT IDNCT07410728

SponsorXijing Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-21

View on ClinicalTrials.gov More Breast Cancer trials