Comparing cosmetic results and patient satisfaction in two breast surgery techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Institute of Oncology
  Budapest, Hungary Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.