Comparing outcomes of immediate and delayed breast reconstruction after mastectomy
Examining and Comparing Patient Satisfaction and Long-term Cosmetic Results Achieved With Implant-based Breast Reconstruction Surgery With Submuscular Silicone Implant After Skin Sparing / Areola Sparing / Nipple Sparing Mastectomy and Contralateral Symmetrization (With Mastopexy and/or Silicone Implant and/or Ultrapro Mesh) With Unilateral Simple Mastectomies and With Bilateral Skin-sparing Mastectomies and Implant-based Immediate Breast Reconstructions. Response-adaptive Prospective Randomized, Comparative Clinical Trial
This study is trying to see how different timing for breast reconstruction after mastectomy affects the appearance, quality of life, and satisfaction of women who have had the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 528 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | National Institute of Oncology, Hungary Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Budapest) |
| Trial ID | NCT04356235 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the cosmetic results, quality of life, and patient satisfaction following different breast reconstruction techniques after mastectomy. It will compare immediate and delayed-immediate implant-based reconstruction procedures, along with contralateral symmetrization techniques. The study will utilize both qualitative and quantitative measures to assess changes over time, focusing on how these changes impact patient satisfaction. Participants will be followed long-term to gather comprehensive data on their experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates are women under 65 with unilateral or bilateral primary breast cancer requiring modern mastectomy techniques and reconstruction.
Not a fit: Patients over 65 years or those with poor health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient satisfaction and quality of life for individuals undergoing breast reconstruction after mastectomy.
How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of immediate versus delayed reconstruction is less commonly explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Budapest
- National Institute of Oncology — Budapest, Hungary (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.