Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol

Recruiting now · Not applicable

Conditions studied: Breast Cancer Female, Breast Cancer, Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT06624917

Run by

University of Rome Tor Vergata

People needed

110

Starts

2024-07-01

Expected to finish

2025-01-01

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients candidates for Breast Conserving Treatment
• ASA score I-II
• Availability to Telehealth assessment in the postoperative period

You may not qualify if…

• 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 it is running

• Università degli Studi di Roma Tor Vergata — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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