Breast Diseases Clinical Trial
Official title:
Oncoplastic Approach to Excisional Breast Biopsies: A Prospective Randomized Controlled Trial
NCT number | NCT02452333 |
Other study ID # | 70904504 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | July 2016 |
Verified date | February 2019 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. However, primary lumpectomy subjects in these studies are mainly patients who have already received the diagnosis of malignancy before the surgery. There is not much comprehensive work reported for patients without the diagnosis of malignancy. In this regard, the investigators believe the intent of the innovative oncoplastic intervention to the breast is underestimated in terms of providing diagnosis simultaneously constituting the basic component of surgical treatment. Thus, the purpose of this prospectively planned study is to provide and investigate the outcomes of an evidence-based oncoplastic approach algorithm for excisional breast biopsies.
Status | Completed |
Enrollment | 80 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who are decided to be suitable for excisional breast biopsy. - Nonpalpable breast lesions suspicious for malignancy where less-invasive approach like fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or vacuum-assisted core biopsy can not provide sufficient diagnostic efficiency for the diagnosis. - Palpable breast lesions when a sufficiently precise diagnosis cannot be reached after practicing less-invasive protocols. Exclusion Criteria: - Patients who are decided to be suitable for mastectomy included protocols as the primary surgery. - Patients who have previously had breast surgery. - Patients who refused excisional breast biopsy. - Patients who do not want to be photographed for cosmetic evaluations. - Patients diagnosed with secondary suspicious breast lesions necessitating surgical intervention during the follow-up period. - Presence of probable multicentric lesions. - Refusal of the patient to participate in the study for any reason. - Aberrations in the normal development and involution of the breast - Injury or trauma history of the breast resulted in deformity. |
Country | Name | City | State |
---|---|---|---|
Turkey | Akdeniz University Hospital | Antalya |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University |
Turkey,
Cardoso MJ, Cardoso JS, Wild T, Krois W, Fitzal F. Comparing two objective methods for the aesthetic evaluation of breast cancer conservative treatment. Breast Cancer Res Treat. 2009 Jul;116(1):149-52. doi: 10.1007/s10549-008-0173-4. Epub 2008 Sep 7. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Harris scale for the cosmetic result. | Patient, surgeon and professional third party observers rate cosmetic results (in terms of color, symmetry, contour and general cosmetic outcome) on a four-point scale: (4) excellent—treated breast nearly identical to untreated breast; (3) good—treated breast slightly different from untreated; (2) fair—treated breast clearly different from untreated but not seriously distorted; (1) poor— treated breast seriously distorted. |
3 months | |
Secondary | Surgical margin positivity for malignancy | Ultimate histopathologic diagnosis | Approximately 2 weeks | |
Secondary | Radiologic assessment of surgical margins | Specimen mammography: Applicable to mammographically depicted lesions only | Intraoperatively assessed | |
Secondary | Morbidity | Bleeding, hematoma, seroma, necrosis or infection after surgery. | 3 months | |
Secondary | Reoperations | Need for any reoperations whether morbidity or surgical margins related. | 3 months | |
Secondary | Breast Size | Unilateral breast volume measured with Tezel method to discriminate small (250 cc and less) vs. medium/large (>250 cc) breasts; determine oncoplastic intervention level (I or II) after assessment of anticipated volume ratio of the resection specimen. | Preoperatively assessed | |
Secondary | Lesion Peripherality | Lesion peripherality along with the videoscopic application preference is decided after assessment of areolar diameter, distance between areolar margin and the skin projection of the central spot of the lesion together with the depth of the lesion; all of which are determinants for ease of access to resection area. | Preoperatively assessed | |
Secondary | Anticipated specimen volume | Preoperatively anticipated specimen volume according to radiologic investigation. | Preoperatively assessed | |
Secondary | Exact specimen volume | True volume of the excised breast tissue | Intraoperatively assessed |
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