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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Arm Endoscopic Nipple-Sparing Mastectomy | Experimental | Eligible participants with breast cancer or ductal carcinoma in situ will undergo endoscopic nipple-sparing mastectomy through a single axillary incision, with immediate direct-to-implant breast reconstruction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Nipple-Sparing Mastectomy (E-NSM) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful 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 | 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 | 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 | From surgery to final pathology assessment, up to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days |
| Participants with at least 1 postoperative complication |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Toesca, MD | Contact | 0119933628 | +39 | antonio.toesca@ircc.it |
| Giada Pozzi, MD | Contact | 0119933676 | +39 | giada.pozzi@ircc.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Unit | Recruiting | Candiolo | Turin | 10060 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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All enrolled participants will undergo endoscopic nipple-sparing mastectomy through a single axillary incision with immediate direct-to-implant reconstruction
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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. |
| 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 | 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 | 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 | 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 | 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 | Baseline (preoperative assessment) and 3 months after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |