This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing direct-to-implant breast reconstruction. The study will assess procedural feasibility, completeness of resection, short-term postoperative complications, and patient-reported outcomes
MINI-B is a single-institution prospective study conducted at the Breast Surgery Unit of Candiolo Cancer Center, Istituto di Candiolo FPO-IRCCS, Torino, Italy. The study will enroll 10 consecutive adult female patients with early-stage invasive breast cancer or ductal carcinoma in situ who are candidates for nipple-sparing mastectomy with direct-to-implant reconstruction and are suitable for a minimally invasive approach. The investigated procedure is endoscopic nipple-sparing mastectomy performed through a single hidden axillary incision using a standardized technique modeled on the robotic nipple-sparing mastectomy procedure already in use at the institution. The study will evaluate feasibility through technical and perioperative parameters, assess resection completeness by margin status, record postoperative complications over 3 months, and collect patient-reported quality-of-life data using BREAST-Q/EORTC questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Endoscopic nipple-sparing mastectomy performed through a single extra-mammary axillary incision using a standardized minimally invasive surgical technique; immediate direct-to-implant reconstruction will be performed according to institutional practice.
Breast Unit
Candiolo, Turin, Italy
RECRUITINGSuccessful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery
Number of participants in whom the planned endoscopic nipple-sparing mastectomy through a single axillary incision is completed without conversion to an open technique
Time frame: During the index surgical procedure
Total operative time
Operative time for the endoscopic nipple-sparing mastectomy procedure, measured from skin incision to completion of wound closure
Time frame: During the index surgical procedure
Negative surgical margin rate
Number of participants with tumor-free surgical margins on final pathological examination of the mastectomy specimen
Time frame: From surgery to final pathology assessment, up to 30 days after surgery
Length of postoperative hospitalization
Postoperative length of hospital stay, measured as the number of days from the date of surgery to the date of hospital discharge.
Time frame: From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days
Participants with at least 1 postoperative complication
Number of participants with at least 1 postoperative complication, defined as nipple-areola complex necrosis, mastectomy skin flap necrosis, surgical-site infection, postoperative bleeding/hematoma, seroma requiring aspiration or drainage, or wound dehiscence.
Time frame: From the date of surgery to 3 months after surgery
Participants with at least 1 major postoperative complication
Number of participants with at least 1 major postoperative complication, defined as any postoperative complication requiring reoperation or rehospitalization, or resulting in implant loss
Time frame: From the date of surgery to 3 months after surgery
BREAST-Q Satisfaction With Breasts score
Patient-reported satisfaction with breasts assessed using the BREAST-Q Reconstruction Module, Satisfaction With Breasts scale. Scores range from 0 to 100, with higher scores indicating greater satisfaction and a better outcome
Time frame: Baseline (preoperative assessment) and 3 months after surgery
BREAST-Q Reconstruction Module Psychosocial Well-Being score
Patient-reported psychosocial well-being assessed using the BREAST-Q Reconstruction Module, Psychosocial Well-Being scale. Scores range from 0 to 100, with higher scores indicating better psychosocial well-being
Time frame: Baseline (preoperative assessment) and 3 months after surgery
BREAST-Q Reconstruction Module Physical Well-Being: Chest score
Patient-reported physical well-being of the chest assessed using the BREAST-Q Reconstruction Module, Physical Well-Being: Chest scale. Scores range from 0 to 100, with higher scores indicating better physical well-being
Time frame: Baseline (preoperative assessment) and 3 months after surgery
BREAST-Q Reconstruction Module Sexual Well-Being score
Patient-reported sexual well-being assessed using the BREAST-Q Reconstruction Module, Sexual Well-Being scale. Scores range from 0 to 100, with higher scores indicating better sexual well-being
Time frame: Baseline (preoperative assessment) and 3 months after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.