Clinical trial · Observational
Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries
Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries. Response-adaptive (RAR) Prospective Randomised, Comperative Clinical Study
- 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)
The aim of this clinical study is to analyze due long term follow-up, the clinical, oncological, aesthetic results and patients' reported quality of life and satisfaction in a responsive-adaptive (RAR) prospective, randomized study at a large number of patients whom receive round-block and retroglandular oncoplastic breast conserving surgeries. According to the study's hypothesis, breast conserving surgery can be oncologically successful and safe with low complication rates resulting in high rate of patient satisfaction and good quality of life, which can be maintained for a long time after WBI with the application of modern oncoplastic breast conserving surgeries. We assume in this study that against of the earliest and mostly studied round-block oncoplastic surgery, the retroglandular technique, firstly reported in the literature by the current authors, is also adequate for oncologically safe, radical tumor removal that comes with low complication rates, suited for adjuvant treatments and able to offer better cosmetic results (NAC does not distorted, and pathological scar will not develop) than round-block OPS and high rate of patient's satisfaction that can be maintained for long-term.
Conditions
Conditions (3)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Patient Satisfaction | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Retroglandular Oncoplastic Breast Conserving Surgeries | Procedure | — | UNRESOLVED |
| Round-block Oncoplastic Breast Conserving Surgeries | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- RB Group
- description
- In this Group Patients receive round-block oncoplastic breast coserving surgery
- interventionNames
- Procedure: Round-block Oncoplastic Breast Conserving Surgeries
- label
- RG Group
- description
- In this Group Patients receive retrogladular oncoplastic breast coserving surgery
- interventionNames
- Procedure: Retroglandular Oncoplastic Breast Conserving Surgeries
Primary outcomes (4)
- measure
- Oncological safety
- timeFrame
- five years follow up
- description
- Correlation analysis of oncological control (overall and disease free survival) achieved by various surgical techniques. The follow-up is similar to the surgical and oncological follow-up in the National Cancer Institute, so it is not a burden for the patients. The overall and disease free survival is calculated from the surgigal treatment to first event. The event such as death, local recurrence, locoregional recurrence or distant metasasis will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * \- Under the age of 65, suffering from unilateral (cT\< 3cm) in situ or invasive breast cancer, who are fit for breast conserving surgeries, who had no previous breast surgery, independent from axillary surgery (sentinel lymph node biopsy or axillary block dissection) Exclusion Criteria: * In case the patient does not volunteer for the examination or the follow-ups * Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without a tumor * Malignant invasive tumor in the past history (except for non-melanoma skin tumors) * Mastectomy performed due to positive resection margin * Prior breast surgery (e.g. aesthetic surgery, breast lift) and/or radiotherapy on the breast or in the axilla * Malignant tumor is not removed completely with pathological examination * Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results * Autoimmune diseases * Tumor requiring mastectomy, or clinically larger than 3 cm tumor primary, or mastitis carcinomatosa, lymphangitis carcinomatosa * Long-term steroid usage, which changed the skin's quality and structure * Patient under foster care, or psychically non-cooperative patient
References
Publications (18)
- BACKGROUNDFisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152. PMID 12393820
- BACKGROUNDVeronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989. PMID 12393819
- BACKGROUNDSingletary SE. Surgical margins in patients with early-stage breast cancer treated with breast conservation therapy. Am J Surg. 2002 Nov;184(5):383-93. doi: 10.1016/s0002-9610(02)01012-7. PMID 12433599
- BACKGROUNDCochrane RA, Valasiadou P, Wilson AR, Al-Ghazal SK, Macmillan RD. Cosmesis and satisfaction after breast-conserving surgery correlates with the percentage of breast volume excised. Br J Surg. 2003 Dec;90(12):1505-9. doi: 10.1002/bjs.4344. PMID 14648728
- BACKGROUNDMatrai Z, Gulyas G, Toth L, Polgar C, Bidlek M, Szabo E, Lang I, Horvath Z, Udvarhelyi N, Kunos C, Savolt A, Pesthy P, Kasler M. [Challenges in oncologic plastic surgery of the breast]. Magy Onkol. 2011 Mar;55(1):40-52. Epub 2011 Mar 31. Hungarian. PMID 21617790
- BACKGROUNDPukancsik D, Kelemen P, Ujhelyi M, Kovacs E, Udvarhelyi N, Meszaros N, Kenessey I, Kovacs T, Kasler M, Matrai Z. Objective decision making between conventional and oncoplastic breast-conserving surgery or mastectomy: An aesthetic and functional prospective cohort study. Eur J Surg Oncol. 2017 Feb;43(2):303-310. doi: 10.1016/j.ejso.2016.11.010. Epub 2016 Dec 5. PMID 28069398
- BACKGROUNDHamdi M. Oncoplastic and reconstructive surgery of the breast. Breast. 2013 Aug;22 Suppl 2:S100-5. doi: 10.1016/j.breast.2013.07.019.