Comparing cosmetic results and patient satisfaction in two breast surgery techniques
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
This study is testing which of two breast surgery techniques, round-block or retroglandular, gives better cosmetic results and patient satisfaction for those undergoing breast cancer treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 242 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | National Institute of Oncology, Hungary Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Budapest) |
| Trial ID | NCT04349527 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the long-term clinical, oncological, aesthetic outcomes, and patient-reported quality of life and satisfaction following two types of oncoplastic breast conserving surgeries: round-block and retroglandular techniques. It employs a responsive-adaptive prospective randomized approach to analyze a large cohort of patients. The hypothesis suggests that both surgical techniques can achieve oncological safety with low complication rates while maintaining high patient satisfaction and quality of life. The study will follow patients over time to assess these outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women under 65 years old with unilateral breast cancer suitable for breast conserving surgeries.
Not a fit: Patients over 65 years old or those with poor general health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical options for breast cancer patients, leading to improved cosmetic outcomes and higher patient satisfaction.
How similar studies have performed: Previous studies have shown promising results with oncoplastic techniques, but the retroglandular approach is relatively novel and less studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Budapest
- National Institute of Oncology — Budapest, Hungary (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.