Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT06569706
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Women between 20 and 75 years.<br><br> - Patient with an indication for curative mastectomy, either unilateral or bilateral,<br> with nipple preservation:<br><br> - Extensive Carcinoma In Situ (CIS), more than 2 cm from the nipple<br><br> - Multicentric Infiltrating Carcinoma (IC), more than 2 cm from the nipple<br><br> - Large volume Infiltrating Carcinoma, more than 2 cm from the nipple<br><br> - IC or CIS for which the patient refuses conservative treatment, more than 2 cm<br> from the nipple<br><br> - Breast volumes: cup sizes A, B, or C as defined by underwear size, and glandular<br> ptosis not exceeding grade 2 according to Regnault's classification<br><br> - Patient wishing to undergo immediate breast reconstruction.<br><br> - WHO/OMS (World Health Organization/Organisation Mondiale de la Santé) performance<br> status <3<br><br>Exclusion Criteria:<br><br> - Cutaneous carcinoma<br><br> - Inflammatory breast<br><br> - History of oncological breast surgery on the same breast<br><br> - Patient who has received radiation treatment on the same breast<br><br> - Breast hypertrophy requiring a nipple-bearing flap<br><br> - Smoking = 10 cigarettes/day<br><br> - BMI > 35<br><br> - Protected patient or unable to give consent according to Article L1121-8 of the<br> French Public Health Code (CSP).<br><br> - Patient participating in another interventional clinical study.<br><br> - ASA (physical status score of the American Society of Anesthesiologists) >2.<br><br> - Pregnant or breastfeeding women according to Article L1121-5 of the CSP.<br><br> - Vulnerable persons (those receiving psychiatric care, those deprived of liberty, and<br> those admitted to a health or social institution) according to Article L1121-6 of<br> the CSP.<br><br> - Absence of effective contraception for patients of childbearing age.<br><br> - Absence of affiliation with a social security scheme.<br><br> - Absence of collected free, informed, and written consent.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients.
- Secondary Outcome Measures
Name Time Method Operative time;Hospital stay;Open surgery conversion rate;Oncologic safety of this approach;Concealed nature of the breast scar;Number of participants with an infection;Skin case necrosis;Complication rates (ischemia);Number of participants with a local haematoma;Post-operative seromas;Necrosis of areolo-nipple plaque;Aesthetic result;Life quality