Breast Cancer Clinical Trial
Official title:
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | October 28, 2019 |
Est. primary completion date | September 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - The study will include 30 women with early-stage breast cancer treated at general surgery department, Assuit University Hospitals - For all patients an informed consent for their inclusion in the study including the use of images will be obtained. - Selection criteria include women with a pre-operative diagnosis (clinical examination, imaging and needle biopsy) of Tis, T1 and T2 tumours without extensive skin involvement. Exclusion Criteria: - • contraindaction for general anesthesia - Positive margin requiring mastectomy - Insufficient remaining breast volume - Diffuse microcalcifications - Multicentric tumor? - Inflammatory breast cancer - Previous radiotherapy - Concomitant disease ( Diabetes, smoking ) |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. — View Citation
Losken A, Dugal CS, Styblo TM, Carlson GW. A meta-analysis comparing breast conservation therapy alone to the oncoplastic technique. Ann Plast Surg. 2014 Feb;72(2):145-9. doi: 10.1097/SAP.0b013e3182605598. — View Citation
Veiga DF, Veiga-Filho J, Ribeiro LM, Archangelo I Jr, Balbino PF, Caetano LV, Novo NF, Ferreira LM. Quality-of-life and self-esteem outcomes after oncoplastic breast-conserving surgery. Plast Reconstr Surg. 2010 Mar;125(3):811-7. doi: 10.1097/PRS.0b013e3181ccdac5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | oncological safety | the pathological report postoperative reveals safety free margins | for 2 weaks | |
Secondary | postoperative recurrence of malignany | follow up any malignancy recurrence post operative by MRI , Mammograghy and look for any new skin nodule appearance | assess for 1 year postoperative | |
Secondary | mortality rate | number of deaths intraoperative and postoperative related to surgery | up to 3 months postoperative for each case | |
Secondary | post operative skin edge ischemia | look for any postoperative ischemia appear in the skin flap as appearance of dark unhealthy tissue in the edge | assess for 1 month postoperative |
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