Comparison Between Prepectoral and Subpectoral Breast Reconstruction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorBeijing Friendship Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
Patients having willingness for breast reconstruction.
Age between 18 to 70 years.
Disqualifiers
patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
Having history of malignant tumor (s) within 5 years.
Patients under immunosuppressive therapy for organ transplantation.
Having continuous systemic steroid hormone therapy.
Trial population
Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) and having willingness for breast reconstruction.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Procedure/SurgeryGroup A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: The prepectoral breast reconstruction1 intervention
Group B: The subpectoral breast reconstruction1 intervention
Trial outcomes
Primary outcomes
1
breast satisfaction
measured by BREAST-Q score
Time frame
12 months after operationSecondary outcomes
1
Physical well-being of chest
measured by BREAST-Q score
Time frame
12 months after operation2
Animation deformity
confirmed by the doctor's physical examination
Time frame
12 months after operation3
Adverse events
according to Clavien-Dindo system
Time frame
within 30 days after surgery4
Local recurrence and distant metastasis of breast cancer
physical examination or imaging examination with histologically confirmed
Time frame
12 months after operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Friendship Hospital
Lead sponsor
Beijing Health Promotion Association
Collaborator
Source ClinicalTrials.gov