Comparison of Safety and Patients-Reported Outcomes Between Single-Port Endoscopic and Convention… (NCT07410728) | Clinical Trial Compass
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.
1This trial compared a single-port endoscopic approach to the conventional nipple-sparing mastectomy — can you explain what 'single-port endoscopic' actually means in practice, and how the incisions and recovery would differ from the standard open technique?
2Since this trial used a questionnaire called the BREAST-Q to measure how patients felt about their outcomes, what kinds of things does that tool capture — like satisfaction with appearance, comfort, or daily function — and how did the two groups compare on those measures?
3The trial is now completed, so would you be able to access or share the results, and do you think the findings would be relevant to my specific situation given my diagnosis and breast anatomy?
4Both techniques in this trial involved immediate implant reconstruction at the same time as the mastectomy — is that approach something you'd recommend for me, or would a staged reconstruction be safer given my individual health profile?
5Since this was a Phase NA comparative study rather than a standard drug or device efficacy trial, how much does the evidence from it influence your recommendation between these two surgical approaches for someone in my position?
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
1
Patient-Reported Outcomes (PROs) as measured by BREAST-Q