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

NCT06624917 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-10-03

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Green Breast Surgery Protocol

A perioperative protocol aiming at reducing environmental impact of surgery, and fast recovery protocol to reduce hospitalization.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Gianluca Vanni, PhD · University of Rome Tor Vergata

  • Oreste Claudio Buonomo, Full Prof · University of Rome Tor Vergata

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-12-01
Completion
2025-01-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06624917 on ClinicalTrials.gov