About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients candidates for Breast Conserving Treatment
ASA score I-II
Availability to Telehealth assessment in the postoperative period
Disqualifiers
Drug addiction
contraindication for locoregional ultrasound-guided procedure (e.g., local infection, allergy to LA)
chronic pain under treatment
pregnancy
Trial design
Parallel
Treatments tested in this trial
Green Breast Surgery Protocol
Procedure/SurgeryA perioperative protocol aiming at reducing environmental impact of surgery, and fast recovery protocol to reduce hospitalization.
Treatment groups
Trial outcomes
Primary outcomes
24 h Post-operative pain at rest
Postoperative Pain at rest with Numeric Pain Rating Scale NPRS (0-10)
24 h Post-operative dynamic pain
Postoperative dynamic Pain with Numeric Pain Rating Scale NPRS (0-10)
Secondary outcomes
Number of hospital admissions after surgery
Number of hospital admissions after surgery
Assessment Telehealth implementation
Assessment Telehealth implementation with Telemedicine Satisfaction Questionnaire (TSQ)
Patients' reported outcome measures
Patients' reported outcome measures with Short-Form Patient Satisfaction Questionnaire (PSQ-18)
Patients' reported outcome measures
Patients' reported outcome measures with The Short Form (36) Health Survey (SF-36)
Other outcomes
Carbon footprint of private patient transport to the hospital
Carbon footprint of private patient transport
Sponsors and contacts
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