Breast Reconstruction Clinical Trial
Official title:
Immediate Breast Reconstruction With Free Greater Omentum for Luminal Breast Cancer Patients
Luminal subtype breast cancer, accounting for 70 to 80% of all breast cancers, has been reported to be associated with good prognosis. However, for the patients with large mass or worse mass position, free greater omentum transplantation may provide a new option for breast reconstruction.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 3, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patient aged 18 -60 years Patient diagnosed with luminal breast cancer No neoadjuvant chemotherapy previously No distant metastasis Suitable for breast conserving surgery Willing and able to give written informed consent to participate in the study including all follow-up examinations Exclusion Criteria: - Participate in another clinicaltrial Bilateral lesions Pregnancy or lactation Greater omentum unable to extract or insufficient omentum Other surgical contraindication |
Country | Name | City | State |
---|---|---|---|
China | Xijing hospital | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | severe related complication | Serious adverse effect occur within 1 years after implantation | 1 year after surgery | |
Secondary | cosmetic outcome | Four-point scale was formulated to evaluate the cosmetic score as excellent (size and shape of recon-structed breast are identical to the original breast); good (deformity of the reconstructed breast in-volved less than 1/4 of the original breast; fair (deformity of the reconstructed breast involves less than 1/4-1/2 of the original breast); and poor (breast deformity involves more than 1/2 of the original breast) | 6 months after surgery | |
Secondary | greater omentum survival | At each follow up time point the proportion of patients with omentum transplantation will be estimated. | 2 and 5 years after surgery | |
Secondary | Patient satisfaction | Patients also rate their level of satisfaction, with the help of a numeric rating scale (NRS: 0-10), in terms of how the outcome met up to their preoperative expectations of the arthroplasty. Finally, they will be asked whether - with their current knowledge of the outcome - they would again choose the operation if they found themselves in similar circumstances to those which prevailed preoperatively. | 6months, 1 and 2 years after surgery |
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