Clinical Trials in Italy / NCT06860217
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Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
NCT06860217 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Breast CancerDCISBRCA Mutation
Investigational drug(s) / intervention(s)
Robotic Nipple-Sparing Mastectomy
Robotic Nipple-Sparing Mastectomy: Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot
Study summary
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.
Eligibility
Inclusion Criteria:
* Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers
* Any age
* Negative preoperative assessment of nipple-areola complex
* Absence of skin involvement
* Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section
* Breast volume ≤ Bra IV
* No hard smoking (defined as \<=20 cigarettes/day)
* Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)
* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
* Patients must be accessible for follow-up
Exclusion Criteria:
* Previous thoracic radiation therapy for any reason
* Inflammatory Breast Cancer
* Pregnancy
* Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
* Uncompensated Diabetes Mellitus
Primary outcome measure(s)
- Surgery time — 1 month
Evaluation of average length of robotic procedure - Post operative complications — 1 month
Number of post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma) - Post operative pain — 1 month
Evaluation of postoperative pain by White and Song scale (minimum value: 0, maximum value: 2 - lower scores indicate higher pain) - Length of stay of patients — 1 month
Evaluation of average length of stay of patients - Patient quality of life after surgery — 5 years
Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome) - Patient satisfaction regarding body image — 5 years
Completion of Hopwood's body image scale (BIS) questionnaire (minimum value: 0, maximum value: 3 - higher scores indicate lower satisfaction) - Patient satisfaction reagarding nipple areola complex — 5 years
Completion of Nipple Areola Complex (NAC) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| European Institute of Oncology | Milan | Italy |
More European Institute of Oncology trials in Italy
PIK3CA Mutational Status Assessment
Recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06860217 on ClinicalTrials.gov ↗ ← All trials in Italy