NCT05833659 Comparison Between Prepectoral and Subpectoral Breast Reconstruction
| NCT ID | NCT05833659 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Friendship Hospital |
| Condition | Stage II Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2022-03-01 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
guoxuan gao, MD
PRINCIPAL INVESTIGATOR
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
Frequently Asked Questions
Who can join the NCT05833659 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Stage II Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05833659 currently recruiting?
Yes, NCT05833659 is actively recruiting participants. Contact the research team at aliceggx@163.com for enrollment information.
Where is the NCT05833659 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05833659 clinical trial?
NCT05833659 is sponsored by Beijing Friendship Hospital. The principal investigator is guoxuan gao, MD at Department of General Surgery, Beijing Friendship Hospital, Capital Medical University. The trial plans to enroll 88 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.