Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patients candidates for Breast Conserving Treatment
• ASA score I-II
• Availability to Telehealth assessment in the postoperative period
Locations
Other Locations
Italy
Università degli Studi di Roma Tor Vergata
RECRUITING
Roma
Contact Information
Primary
Oreste Claudio Buonomo, Full Prof
marco.materazzo@ptvonline.it
3395685883
Backup
Marco Materazzo, PhD Fellow
marco.materazzo@ptvonline.it
3395685883
Time Frame
Start Date:2024-07-01
Estimated Completion Date:2025-01-01
Participants
Target number of participants:110
Treatments
Experimental: Green Breast Surgery
Preoperative assessment:~Counsel patients before admission.~* Encourage 1 month of no alcohol and smoking before surgery.~* Recommend weight loss for BMI \> 30 with exercise.~Operative assessment:~* Admit to Day Surgery Unit.~* Allow clear liquids until 2 hours before surgery.~* Give maltodextrin 2 hours prior to surgery.~* Prescribe antibiotic prophylaxis if needed.~* Prescribe post-op anti-nausea/vomiting medication.~* Use Awake Breast Surgery Protocol with Peripheral Nerve Blocks (ESP or PECS1).~* Follow Intercollage Green Theatre checklist.~* Post-operative assessment:~Apply personalized DVT prophylaxis.~* Allow food and water shortly after surgery.~* Encourage mobilization a few hours post-surgery.~* Use telemedicine for first follow-ups and later as needed.~* Scheduled Time Frame pain (NRS scale) and quality of life (PSQ-18, SF-36, QoL, Breast-Q, TSQ-WT) assessment~* Check for complications 30 days after surgery.
No_intervention: Conventional Surgery
Preoperative assessment:~Counsel patients before admission.~* Encourage 1 month of no alcohol and smoking before surgery.~* Recommend weight loss for BMI \> 30 with exercise.~Operative assessment:~* Admit to surgical unit according to the surgeon preference~* Allow clear liquids until 2 hours before surgery.~* Give maltodextrin 2 hours prior to surgery.~* Prescribe antibiotic prophylaxis if needed.~* Prescribe post-op anti-nausea/vomiting medication.~* Intraoperative management according to Surgeon and Anesthesiologist~Post-operative assessment:~* Apply personalized DVT prophylaxis.~* Allow food and water shortly after surgery.~* Encourage mobilization according to the intraoperative managment.~* Use telemedicine for first follow-ups and later as needed.~* Scheduled Time Frame pain (NRS scale) and quality of life (PSQ-18, SF-36, QoL, Breast-Q, TSQ-WT) assessment~* Check for complications 30 days after surgery.