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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorUniversity of Rome Tor Vergata

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Green Breast Surgery Protocol

    Procedure/Surgery

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Green Breast SurgeryExperimental treatment 1 intervention
Group B: Conventional SurgeryNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

24 h Post-operative pain at rest

Postoperative Pain at rest with Numeric Pain Rating Scale NPRS (0-10)

Time frame
24 hours after surgery
2

24 h Post-operative dynamic pain

Postoperative dynamic Pain with Numeric Pain Rating Scale NPRS (0-10)

Time frame
24 hours after surgery

Secondary outcomes

1

Number of hospital admissions after surgery

Number of hospital admissions after surgery

Time frame
30 days after surgery
2

Assessment Telehealth implementation

Assessment Telehealth implementation with Telemedicine Satisfaction Questionnaire (TSQ)

Time frame
30 days after surgery
3

Patients' reported outcome measures

Patients' reported outcome measures with Short-Form Patient Satisfaction Questionnaire (PSQ-18)

Time frame
30 days after surgery
4

Patients' reported outcome measures

Patients' reported outcome measures with The Short Form (36) Health Survey (SF-36)

Time frame
30 days after surgery

Other outcomes

1

Carbon footprint of private patient transport to the hospital

Carbon footprint of private patient transport

Time frame
30 days after surgery

Sponsors and contacts

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