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Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for cancer

Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for cancer: A retrospective cohort study (SPINER)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13005336
Enrollment
100
Registered
2022-12-30
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Breast cancer Cancer

Interventions

This study was a retrospective cohort study. Single-port insufflation endoscopic nipple-sparing subcutaneous mastectomy combined with immediate prosthetic reconstruction (SIE-NSM-IPR) using prosthesis
this minimises the surgical scar and ensures that it is not in a high-tension area. Conventional open-nipple and areola-sparing subcutaneous mastectomy combined with immediate reconstruction using pro

Sponsors

Beijing Friendship Hospital
Lead Sponsor
Beijing Municipal Health Bureau
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged between 18 to 70 years old 2. Diagnosis of stage I or II invasive breast carcinoma or carcinoma in situ 3. Original lesion =3 cm in diameter 4. Distance between the lesion and the nipple-areola complex =2 cm 5. Clinically negative axillary nodes 6. Tumor constrained to the mammary gland 7. Tumor is not invading the nipple-areola complex or the skin 8. Negative sentinel lymph node biopsy 9. Eastern Cooperative Oncology Group score from 0-2 10. Patient not suitable for breast-conserving surgery and not requesting mastectomy and breast reconstruction

Exclusion criteria

Exclusion criteria: Positive sentinel lymph node biopsy

Design outcomes

Primary

MeasureTime frame
Postoperative complications measured using data sources collected from the medical records according to the Clavien-Dindo classification 1 month after surgery

Secondary

MeasureTime frame
1. Aesthetic satisfaction of patients measured using the BREAST-Q questionnaire 6 months after surgery 2. Survival data measured using data sources collected from the medical records for all patients who were followed up at the outpatient clinic re-examination or through a telephone call every 6 months to record whether there was local recurrence or metastasis

Countries

China

Outcome results

None listed

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