To Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy; Procedure: single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection

• Registration Number: NCT06561646
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the abdominal endoscopic surgery system and evaluate the effectiveness and safety of the single-port robotic-assisted breast surgery in breast cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Last Update Submitted: 2024-08-16
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20
• Study Start: 2024-08-21
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1. Male breast cancer or inflammatory breast cancer;
2. Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
3. The clinical data is basically incomplete;
4. Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
5. Bilateral breast cancer surgery;
6. Other surgical methods;
7. Preoperative distant metastasis or supraclavicular lymph node dissection;
8. Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;
9. The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;
10. Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-port robotic-assisted breast surgery	single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection	the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer; single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection
single-port robotic-assisted breast surgery	single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy	the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer; single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection

Primary Outcome Measures

Name	Time	Method
Local recurrence free survival rate	Ten years	Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China