NCT06624917 Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol
| NCT ID | NCT06624917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rome Tor Vergata |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-07-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast Cancer (BC) is the primary oncological diagnosis in women, with the annual incidence expected to exceed 3 million new cases by 2040 due to population growth and aging. During the COVID-19 pandemic, novel methods were adopted worldwide to provide continuous patient care, including telehealth, fast-track protocols such as awake surgery in breast cancer. These innovative techniques allowed for improved access to care, and additionally reduced emissions with environmental impact, better resource utilization, and improved continuity of care, but their impact post-pandemic era has not been investigated. A current issue is the environmental impact of hospitals, particularly operating rooms, as it has been analysed that 25-30% of hospital waste comes from these areas. A Breast Green Surgery protocol (BuGS protocol) has been designed to reduce Breast Surgery Impact of care, evaluating for the synergistic effect of different procedure for the first time on classic Clincal Outcome, Patients' Reported Outcome Measure (PROM), and Environment Related Outcome Measure (EROM) in breast cancer surgery. Main hypothesis is that BuGs protocol will provide a significant reduction in carbon footprint of care (EROM) without impacting clinical outcome and PROMs.
Eligibility 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
Contact & Investigator
Gianluca Vanni, PhD
PRINCIPAL INVESTIGATOR
University of Rome Tor Vergata
Frequently Asked Questions
Who can join the NCT06624917 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06624917 currently recruiting?
Yes, NCT06624917 is actively recruiting participants. Contact the research team at marco.materazzo@ptvonline.it for enrollment information.
Where is the NCT06624917 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06624917 clinical trial?
NCT06624917 is sponsored by University of Rome Tor Vergata. The principal investigator is Gianluca Vanni, PhD at University of Rome Tor Vergata. The trial plans to enroll 110 participants.
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