Comparing cosmetic results and patient satisfaction of two breast surgery techniques
Examining the Cosmetic Results and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy of Ptotic Breast Followed by Delayed-immediate Submuscular Implant Based- Breast Reconstruction Surgery, and Comparing it to Submuscular Delayed- Immediate Implant- Based Breast Reconstruction Procedures After Skin- Sparing Mastectomy. Response-adaptive, Prospective Randomized Clinical Trial
This study is trying to see if a newer breast surgery technique gives better cosmetic results and patient satisfaction compared to a traditional method for women under 65 with breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | National Institute of Oncology, Hungary Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT04345081 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the cosmetic outcomes, quality of life, and patient satisfaction following two different breast surgery techniques: Skin Reducing Nipple Sparing Mastectomy (SRNSM) and Skin Sparing Mastectomy (SSM). It will utilize both qualitative and quantitative measures to assess the effectiveness of SRNSM, particularly in patients with pendulous or ptotic breasts, compared to the more traditional SSM approach. The study will involve patients under 65 years old with primary breast cancer who require mastectomy and implant-based reconstruction, and will follow them over a long-term period to gather comprehensive data on their experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women under 65 years old with uni- or bilateral primary breast cancer who require skin sparing or nipple sparing mastectomy.
Not a fit: Patients over 65 years old or those with poor general health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cosmetic outcomes and higher patient satisfaction for women undergoing breast reconstruction after mastectomy.
How similar studies have performed: Previous studies have shown promising results with similar surgical techniques, suggesting that this approach may be effective.
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 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 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) * 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
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.