Oncoplastic Approach to Excisional Breast Biopsies
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFebruary 28, 2019
February 1, 2019
1.2 years
May 18, 2015
February 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Surgical margin positivity for malignancy
Approximately 2 weeks
Radiologic assessment of surgical margins
Intraoperatively assessed
Morbidity
3 months
Reoperations
3 months
Breast Size
Preoperatively assessed
- +3 more secondary outcomes
Study Arms (2)
Evidence-based Oncoplastic Algorithm
EXPERIMENTALOncoplastic Approach Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment
Control
EXPERIMENTAL\- Conventional Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment
Interventions
Evidence based quadrant by quadrant oncoplastic algorithm reinforced with videoscopic applications for peripheral lesions.
Tezel Method is a simple, accurate and non-invasive method of measuring differences in breast volume based on Archimedes' principle
Cosmetic Assessment with Harris scale graded by patient, surgeon and professional third party. A standardised photograph of front, side and mediolateral oblique views will be taken using a digital camera for professional third party observers.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akdeniz University Hospital
Antalya, Turkey (Türkiye)
Related Publications (10)
Santos G, Urban C, Edelweiss MI, Zucca-Matthes G, de Oliveira VM, Arana GH, Iera M, Rietjens M, de Lima RS, Spautz C, Kuroda F, Anselmi K, Capp E. Long-Term Comparison of Aesthetical Outcomes After Oncoplastic Surgery and Lumpectomy in Breast Cancer Patients. Ann Surg Oncol. 2015 Aug;22(8):2500-8. doi: 10.1245/s10434-014-4301-6. Epub 2014 Dec 18.
PMID: 25519931BACKGROUNDMcCulley SJ, Macmillan RD. Planning and use of therapeutic mammoplasty--Nottingham approach. Br J Plast Surg. 2005 Oct;58(7):889-901. doi: 10.1016/j.bjps.2005.03.008.
PMID: 16043150BACKGROUNDClough KB, Ihrai T, Oden S, Kaufman G, Massey E, Nos C. Oncoplastic surgery for breast cancer based on tumour location and a quadrant-per-quadrant atlas. Br J Surg. 2012 Oct;99(10):1389-95. doi: 10.1002/bjs.8877.
PMID: 22961518BACKGROUNDCardoso 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.
PMID: 18777134BACKGROUNDYamashita K, Shimizu K. Transaxillary retromammary route approach of video-assisted breast surgery enables the inner-side breast cancer to be resected for breast conserving surgery. Am J Surg. 2008 Oct;196(4):578-81. doi: 10.1016/j.amjsurg.2008.06.028.
PMID: 18809067BACKGROUNDSerra-Renom JM, Serra-Mestre JM, Martinez L, D'Andrea F. Endoscopic reconstruction of partial mastectomy defects using latissimus dorsi muscle flap without causing scars on the back. Aesthetic Plast Surg. 2013 Oct;37(5):941-9. doi: 10.1007/s00266-013-0192-3. Epub 2013 Jul 23.
PMID: 23877754BACKGROUNDTezel E, Numanoglu A. Practical do-it-yourself device for accurate volume measurement of breast. Plast Reconstr Surg. 2000 Mar;105(3):1019-23. doi: 10.1097/00006534-200003000-00028.
PMID: 10724264BACKGROUNDNakajima H, Fujiwara I, Mizuta N, Sakaguchi K, Hachimine Y, Magae J. Video-assisted skin-sparing breast-conserving surgery for breast cancer and immediate reconstruction with autologous tissue: clinical outcomes. Ann Surg Oncol. 2009 Jul;16(7):1982-9. doi: 10.1245/s10434-009-0429-1. Epub 2009 Apr 24.
PMID: 19390899BACKGROUNDNakajima H, Fujiwara I, Mizuta N, Sakaguchi K, Hachimine Y. Video-assisted skin-sparing breast-conserving surgery for breast cancer and immediate reconstruction with autologous tissue. Ann Surg. 2009 Jan;249(1):91-6. doi: 10.1097/SLA.0b013e31818e3fa6.
PMID: 19106682BACKGROUNDZaha H. Partial breast reconstruction for the medial quadrants using the omental flap. Ann Surg Oncol. 2014 Oct;21(10):3358. doi: 10.1245/s10434-014-3907-z. Epub 2014 Jul 26.
PMID: 25063006BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cumhur Arıcı, Professor
Akdeniz University, General Surgery Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2015
First Posted
May 22, 2015
Study Start
May 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
February 28, 2019
Record last verified: 2019-02