Comparison Between Prepectoral and Subpectoral Breast Reconstruction
NCT ID: NCT05833659
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
88 participants
OBSERVATIONAL
2022-03-01
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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The prepectoral breast reconstruction
The patients received prepectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy
The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction
The subpectoral breast reconstruction
The patients received subpectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy
The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction
Interventions
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The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Beijing Health Promotion Association
UNKNOWN
Beijing Friendship Hospital
OTHER
Responsible Party
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Principal Investigators
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guoxuan gao, MD
Role: PRINCIPAL_INVESTIGATOR
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
Locations
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Beijing Friendship Hospital, Capital medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RESPECT
Identifier Type: -
Identifier Source: org_study_id
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