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Da Vinci robot-assisted versus open nipple-sparing mastectomy combined with stage I prosthesis breast reconstruction in early breast cancer:A multicenter prospective cohort

Da Vinci robot-assisted versus open nipple-sparing mastectomy combined with stage I prosthesis breast reconstruction in early breast cancer:A multicenter prospective cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092231
Enrollment
Unknown
Registered
2024-11-12
Start date
2023-10-03
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Research Group (Robot-assisted nipple-sparing mastectomy combined with stage I prosthesis breast reconstruction):None
control group (Traditional open surgery nipple-sparing mastectomy combined with stage I prosthesis breast reconstruction):None

Sponsors

the First Affiliated Hospital of Army Military Medical University (Southwest Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1: Aged 18-60 years old 2: Pathology confirmed invasive breast cancer 3: T1-2N0M0 is unwilling to undergo breast preservation surgery or T3N0M0 is not suitable for breast preservation surgery after neoadjuvant therapy 4: Breast volume less than 500 ml, no severe ptosis 5: The tumor did not invade the nipple areola and subcutaneous tissue 6: Preoperative ECOG physical status score was 0~1 7: Preoperative ASA score was I-III 8: Underwent breast prosthesis reconstruction, agreed to participate in the study and signed the informed consent

Exclusion criteria

Exclusion criteria: 1: Prophylactic resection of both breast cancers or the opposite breast is required 2: Postoperative radiotherapy was required 3: Preoperative assessment was severe dysfunction of heart, liver, lung, kidney and other important organs, which could not tolerate anesthesia surgery and necessary comprehensive treatment 4: History of malignant tumors (except thyroid cancer, skin basal cell carcinoma, etc.) 5: Long history of smoking 6: Severe mental illness 7: History of unstable angina pectoris or myocardial infarction, cerebral infarction, or cerebral hemorrhage within 6 months 8: Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS );Disease-free survival;

Secondary

MeasureTime frame
Relapse-free survival;Complication rate ;Degree of satisfaction;

Countries

China

Contacts

Public ContactLi Chen

The First Affiliated Hospital (Southwest Hospital) of Army Medical University

Chenli@tmmu.edu.cn+86 133 8966 9379

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026