Clinical trial · Observational
Comparison Between Prepectoral and Subpectoral Breast Reconstruction
The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction. This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- The prepectoral breast reconstruction
- description
- The patients received prepectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy
- interventionNames
- Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
- label
- The subpectoral breast reconstruction
- description
- The patients received subpectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy
- interventionNames
- Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Primary outcomes (1)
- measure
- breast satisfaction
- timeFrame
- 12 months after operation
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy. 2. Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy. 3. Patients having willingness for breast reconstruction. 4. Age between 18 to 70 years. 5. Maximum diameter of the cancer lesion ≤ 3 cm. 6. Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall. 7. The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2. Exclusion Criteria: 1. patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months. 2. Having history of malignant tumor (s) within 5 years. 3. Patients under immunosuppressive therapy for organ transplantation. 4. Having continuous systemic steroid hormone therapy. 5. Pregnant or lactating women.
References
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