Evaluating the Green Breast Surgery Protocol for Breast Cancer
Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol
This study is testing a new way of doing breast cancer surgery that uses a different type of anesthesia to see if it helps patients recover better and is better for the environment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Rome Tor Vergata Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06624917 on ClinicalTrials.gov |
What this trial studies
This study assesses the oncological safety, quality of life, and environmental impact of the Green Breast Surgery Protocol (BuGS) for patients undergoing breast-conserving treatment. It aims to compare the outcomes of traditional general anesthesia with Monitored Anesthesia Care (MAC) to enhance recovery and reduce the environmental footprint of surgical procedures. The study will utilize telehealth assessments to monitor postoperative recovery and patient-reported outcomes, focusing on both clinical effectiveness and sustainability in breast cancer care.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with breast cancer who are eligible for breast-conserving treatment and have an ASA score of I-II.
Not a fit: Patients with drug addiction, contraindications for locoregional procedures, chronic pain under treatment, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve recovery times and quality of life for breast cancer patients while minimizing the environmental impact of surgical procedures.
How similar studies have performed: Other studies have shown promising results with similar conservative surgical approaches and anesthesia techniques, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients candidates for Breast Conserving Treatment * ASA score I-II * Availability to Telehealth assessment in the postoperative period Exclusion Criteria: * Drug addiction * contraindication for locoregional ultrasound-guided procedure (e.g., local infection, allergy to LA) * chronic pain under treatment * pregnancy * No follow-up planned in our facility
Where this trial is running
Roma
- Università degli Studi di Roma Tor Vergata — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Gianluca Vanni, PhD — University of Rome Tor Vergata
- Study coordinator: Oreste Claudio Buonomo, Full Prof
- Email: marco.materazzo@ptvonline.it
- Phone: 3395685883
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.