Status:
RECRUITING
Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques
Lead Sponsor:
National Institute of Oncology, Hungary
Conditions:
Mastectomy; Lymphedema
Breast Cancer
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 modern skin sparing mastectomy, nipple sparing mastectomy or areola sparing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstrucion on the ipsilateral side and symmetrisation on the contralateral side ( mastopexy and/or implant based reconstruction and/or breast sling with ultrapro mesh)
- Control group: patients under 65 years with unilateral simplex mastectomy without breast 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)
- Mastectomyand 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
- If breast correction performed during the 5 years follow up
Key Trial Info
Start Date :
April 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 10 2027
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT04356235
Start Date
April 27 2020
End Date
April 10 2027
Last Update
April 22 2020
Active Locations (1)
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1
National Institute of Oncology
Budapest, Hungary, 1122