Clinical trial · Interventional
Oncoplastic Approach to Excisional Breast Biopsies
Oncoplastic Approach to Excisional Breast Biopsies: A Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Diseases | — | UNRESOLVED | — |
| Breast Neoplasms Diagnosis | — | UNRESOLVED | — |
| Deformity of Reconstructed Breast | — | UNRESOLVED | — |
| Neoplasm of Female Breast | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Excisional Breast Biopsy | Procedure | — | UNRESOLVED |
| Cosmetic Assessment | Other | — | UNRESOLVED |
| Oncoplastic Approach Excisional Breast Biopsy | Procedure | — | UNRESOLVED |
| Tezel Method of Breast Volume Measurement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Evidence-based Oncoplastic Algorithm
- description
- Oncoplastic Approach Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment
- interventionNames
- Procedure: Oncoplastic Approach Excisional Breast Biopsy
- Other: Tezel Method of Breast Volume Measurement
- Other: Cosmetic Assessment
- type
- EXPERIMENTAL
- label
- Control
- description
- \- Conventional Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment
- interventionNames
- Procedure: Conventional Excisional Breast Biopsy
- Other: Tezel Method of Breast Volume Measurement
- Other: Cosmetic Assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDSantos 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 25519931
- BACKGROUNDMcCulley 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 16043150
- BACKGROUNDClough 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 22961518
- BACKGROUNDCardoso 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 18777134
- BACKGROUNDYamashita 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 18809067
- BACKGROUNDSerra-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 23877754
- BACKGROUNDTezel 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.