Comparing cosmetic results and patient satisfaction of 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 observational study aims to evaluate the cosmetic outcomes, quality of life, and patient satisfaction following two different breast surgery techniques: Skin Reducing Nipple Sparing Mastectomy (SRNSM) and Skin Sparing Mastectomy (SSM). It will utilize both qualitative and quantitative measures to assess the effectiveness of SRNSM, particularly in patients with pendulous or ptotic breasts, compared to the more traditional SSM approach. The study will involve patients under 65 years old with primary breast cancer who require mastectomy and implant-based reconstruction, and will follow them over a long-term period to gather comprehensive data on their experiences and outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing skin sparing mastectomy, nipple sparing mastectomy or patients require risk reducing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstruction.

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 the tumorous disease
* Malignant invasive tumor in the past history (except for non-melanoma skin tumors)
* Mastectomy and reconstruction performed due pregnancy associated breast cancer
* Prior breast surgery (e.g. aesthetic surgery, mastopexy) 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
* Mastitis carcinomatosa
* Lymphangitis carcinomatosa
* Open wound therapy due SSI
* 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.