Comparing quality of life and cosmetic outcomes in breast-conserving surgery methods
Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method (TRIGUIDE Trial) - A Randomized Trial
This study is testing which method of breast-conserving surgery helps women with breast cancer feel better about their bodies and quality of life after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06186011 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the quality of life and cosmetic outcomes for patients undergoing breast-conserving surgery for breast cancer, based on different localization methods: intraoperative ultrasound, wire-guided surgery, and radioactive seed localization. Participants will be randomly assigned to one of the three methods, and their experiences will be assessed post-surgery. The study focuses on how these methods impact not only the surgical results but also the patients' body image and overall quality of life. By understanding these factors, the trial seeks to improve surgical techniques and patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with non-palpable infiltrating breast carcinoma classified as T1 and T2, who are eligible for primary breast-conserving surgery.
Not a fit: Patients with lesions smaller than 5mm, multicentric tumors, or those requiring extensive oncoplastic techniques or mastectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the cosmetic outcomes and quality of life for breast cancer patients undergoing surgery.
How similar studies have performed: Other studies have shown promising results in improving cosmetic outcomes and quality of life through various surgical techniques, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with non-palpable and ecovisible infiltrating breast carcinoma, classified as T1 and T2, eligible for primary breast-conserving surgery (BCS) Exclusion Criteria: * lesions \<5mm * multicentric tumors * extensive calcifications not visible by ultrasound * level III oncoplastic techniques or mastectomy
Where this trial is running
Barcelona
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Eduard Mension, MD PhD — Hospital Clinic of Barcelona
- Study coordinator: Eduard Mension, MD PhD
- Email: edmension@gmail.com
- Phone: +34 626207171
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.