Status:
RECRUITING
Examining the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, and Comparing it to Classic Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgeries
Lead Sponsor:
National Institute of Oncology, Hungary
Conditions:
Breast Cancer
Mastectomy; Lymphedema
Eligibility:
FEMALE
18-65 years
Brief Summary
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in c...
Detailed Description
Introduction The indication of total breast removal is primarily the part of a correct oncological therapy, but secondly the removal of the full parenchyma can be prophylactic among high risk patients...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 5 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04345081
Start Date
April 18 2020
End Date
April 5 2027
Last Update
April 21 2020
Active Locations (1)
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1
National Institute of Oncology
Budapest, Hungary, 1122