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

Launched by NATIONAL INSTITUTE OF ONCOLOGY, HUNGARY · Apr 21, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring how different methods of breast reconstruction after a mastectomy affect cosmetic results, quality of life, and patient satisfaction over time. Specifically, it compares immediate reconstruction with silicone implants to delayed reconstruction methods. Researchers believe that as time passes, the reconstructed breast may not look or feel the same as the natural breast, leading to greater asymmetry and possibly lower patient satisfaction. The study aims to gather important information that can help patients and doctors make better decisions about breast reconstruction options and their long-term outcomes.

To participate in this study, women under 65 years old with early to moderate-stage breast cancer who need certain types of mastectomy may be eligible. Participants will receive either immediate or delayed reconstruction and may also undergo procedures to make the breasts look more symmetrical. Throughout the trial, patients will be monitored over time to assess changes in their satisfaction and the appearance of their breasts. It’s important for potential participants to understand that the study aims to provide valuable insights that could improve future surgical planning and patient care.

Gender

FEMALE

Eligibility criteria

• 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