- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03370250
Immediate Breast Reconstruction With Free Greater Omentum
Immediate Breast Reconstruction With Free Greater Omentum for Luminal Breast Cancer Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mei Ling Huang, MD
- Phone Number: 029-84775271
- Email: huangmeiling@126.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital
-
Contact:
- Mei Ling Huang, MD
- Phone Number: 029-84775271
- Email: huangmeiling@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
severe related complication
Time Frame: 1 year after surgery
|
Serious adverse effect occur within 1 years after implantation
|
1 year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cosmetic outcome
Time Frame: 6 months after surgery
|
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
|
greater omentum survival
Time Frame: 2 and 5 years after surgery
|
At each follow up time point the proportion of patients with omentum transplantation will be estimated.
|
2 and 5 years after surgery
|
Patient satisfaction
Time Frame: 6months, 1 and 2 years after surgery
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KY20162047-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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