AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

Recruitingn/aAges 18 Years - 65 YearsFemaleNational Institute of Oncology, Hungary
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 cosmetic results, quality of life and patient satisfaction after breast reconstructive surgery with silicone implant (following SSM, ASM or NSM mastectomy) and symmetrization (mastopexy and/or silicone implant and/or Ultrapro mesh sling technique) over time. According to the hypothesis of the study, the results of implant-based breast reconstruction and symmetrization following advanced postmastectomy techniques significantly decrease over time and later results limited patient satisfaction rate. This is mainly due to the fact that over time, the natural breast differs from the reconstructed breast with silicone implant. Because of the different biological properties (gravity results ptosis

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 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) * 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
๐Ÿ’Š

What it tests

  • A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction
  • B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling
  • C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
  • D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation
  • E: unilateral simple mastectomy
๐Ÿ“

Where

1 site
National Institute of Oncology
Budapest, Hungary
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy