Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT06624917

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

Led by University of Rome Tor Vergata · Updated on 2024-10-03

110

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients candidates for Breast Conserving Treatment
  • ASA score I-II
  • Availability to Telehealth assessment in the postoperative period
Not Eligible

You will not qualify if you...

  • Drug addiction
  • Contraindication for locoregional ultrasound-guided procedure such as local infection or allergy to local anesthesia
  • Chronic pain under treatment
  • Pregnancy
  • No follow-up planned in our facility

AI-Screening

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Trial Site Locations

Total: 1 location

1

Università degli Studi di Roma Tor Vergata

Roma, Italy, 00133

Actively Recruiting

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Research Team

O

Oreste Claudio Buonomo, Full Prof

CONTACT

M

Marco Materazzo, PhD Fellow

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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