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

Study acronym: BuGs
StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 3, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06624917
Lead Sponsor University of Rome Tor Vergata
Conditions
(from sponsor)
Breast Cancer Female, Breast Cancer, Breast Neoplasms
Related terms Breast Neoplasms
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov