Comparison of Cosmetic Results, Quality of Life, and Patient Satisfaction With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries
Response-adaptive Prospective Randomized Clinical Study
Led by National Institute of Oncology, Hungary · Updated on 2020-04-21
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260 weeks
Total Duration
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What this Trial Is About
Researchers are evaluating the clinical, oncological, and aesthetic outcomes and patients' quality of life and satisfaction following two types of oncoplastic breast conserving surgeries in women with early unilateral breast cancer. This responsive-adaptive prospective randomized study compares the widely studied round-block technique with the newer retroglandular technique, hypothesizing both provide safe tumor removal with low complication rates, good cosmetic results, and sustained patient satisfaction after whole breast irradiation.
Participants receive either round-block or retroglandular oncoplastic breast conserving surgery, both standardized surgical procedures adapted to tumor location and breast anatomy. The round-block method involves de-epithelizing and mobilizing breast tissue near the tumor, while the retroglandular technique includes dissecting tissue beneath the breast and muscle. After surgery, patients undergo standard oncological treatments, and follow-up includes regular assessments over five years.
Participants undergo preoperative examinations including biopsies, imaging, and breast measurements, with data collected on tumor characteristics and patient health. Postoperative follow-up occurs at 4-6 weeks, 3 months, and then every 6 months for 5 years, involving photo documentation, breast measurements, software analysis, and quality of life questionnaires. Researchers monitor oncological safety, cosmetic outcomes, patient satisfaction, complications, and quality of life throughout the study period.
CONDITIONS
Brief Title
Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries
Who Can Participate
Age: 18Years - 65Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Female, aged 18 to 65 years
Diagnosed with unilateral in situ or invasive breast cancer smaller than 3 cm
Fit for breast conserving surgery
No previous breast surgery
Eligible regardless of axillary surgery type (sentinel lymph node biopsy or axillary block dissection)
You will not qualify if you...
Not volunteering for the examinations or follow-ups
Age over 65 or poor general health with life expectancy less than 2 years without tumor
History of malignant invasive tumors except non-melanoma skin tumors
Mastectomy performed due to positive resection margin
Prior breast surgery (including aesthetic or breast lift) or radiotherapy on breast or axilla
Incomplete tumor removal confirmed pathologically
Severe non-surgical complications affecting aesthetic or functional results
Autoimmune diseases
Tumor requiring mastectomy, tumor larger than 3 cm, mastitis carcinomatosa, or lymphangitis carcinomatosa
Long-term steroid use affecting skin quality and structure
Patient in foster care or psychically uncooperative patient
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - 1 day
Participants undergo either round-block or retroglandular oncoplastic breast conserving surgery as part of their treatment.
1 surgical procedure (in-person)
Post-operative Follow-up
Duration - Up to 5 years
Participants attend follow-up visits for photo documentation, body measurements, and quality of life assessments to monitor cosmetic results, satisfaction, and health status.
Visits at 4-6 weeks, 3 months, then every 6 months up to 5 years
Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer.
Objective decision making between conventional and oncoplastic breast-conserving surgery or mastectomy: An aesthetic and functional prospective cohort study.
Evaluation of a Retroglandular Oncoplastic Technique as a Standard Level I Oncoplastic Breast-Conserving Surgery: A Retrospective Clinicopathologic Study of 102 Patients With Breast Cancer.