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

NCT06624917 | Recruiting DMC

• 1 other identifier: BuGS 1.2024
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer Female; Breast Cancer; Breast Neoplasms

Keywords

Breast Neoplasm; Environment Related Outcome Measure; Patients' Reported Outcome Measure

Outcome Measures

Primary Outcomes (2)

• 24 h Post-operative pain at rest

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

  24 hours after surgery

• 24 h Post-operative dynamic pain

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

  24 hours after surgery

Secondary Outcomes (12)

• Number of hospital admissions after surgery

  30 days after surgery

• Assessment Telehealth implementation

  30 days after surgery

• Patients' reported outcome measures

  30 days after surgery

• Patients' reported outcome measures

  30 days after surgery

• Patients' reported outcome measures

  30 days after surgery

Other Outcomes (1)

• Carbon footprint of private patient transport to the hospital

  30 days after surgery

Study Arms (2)

Green Breast Surgery

EXPERIMENTAL

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.

Procedure: Green Breast Surgery Protocol

Conventional Surgery

NO INTERVENTION

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.

Interventions

Green Breast Surgery Protocol PROCEDURE

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

Green Breast Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients candidates for Breast Conserving Treatment
• ASA score I-II
• Availability to Telehealth assessment in the postoperative period

You may not qualify if:

• Drug addiction
• contraindication for locoregional ultrasound-guided procedure (e.g., local infection, allergy to LA)
• chronic pain under treatment
• pregnancy
• No follow-up planned in our facility

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Università degli Studi di Roma Tor Vergata

Roma, 00133, Italy

RECRUITING

Related Publications (3)

• Materazzo M., Facchini A., Garozzo D., Buonomo C., Pellicciaro M., Vanni G. Maintaining good practice in breast cancer management and reducing the carbon footprint of care: study protocol and preliminary results WCRJ 2022; 9: e2438 DOI: 10.32113/wcrj_202211_2438

  BACKGROUND

• Vanni G, Caiazza G, Materazzo M, Storti G, Pellicciaro M, Buonomo C, Natoli S, Fabbi E, Dauri M. Erector Spinae Plane Block Versus Serratus Plane Block in Breast Conserving Surgery: Alpha Randomized Controlled Trial. Anticancer Res. 2021 Nov;41(11):5667-5676. doi: 10.21873/anticanres.15383.

  PMID: 34732440 BACKGROUND

• Vanni G, Materazzo M, Pellicciaro M, Marino D, Buonomo OC. From Patient Reported Outcome Measure (PROM) to Environment Related Outcome Measure (EROM): Towards "Green Breast Surgery". In Vivo. 2023 Jul-Aug;37(4):1867-1872. doi: 10.21873/invivo.13278.

  PMID: 37369495 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gianluca Vanni, PhD

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

• Oreste Claudio Buonomo, Full Prof

  University of Rome Tor Vergata

  STUDY CHAIR

Central Study Contacts

Oreste Claudio Buonomo, Full Prof

CONTACT

3395685883; marco.materazzo@ptvonline.it

Marco Materazzo, PhD Fellow

CONTACT

3395685883; marco.materazzo@ptvonline.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Once enrolled patients were randomized to receive
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Once enrolled in the study population, patients will be divided prior to admission into the two study groups (Green Breast Surgery Group and Conventional Care Group).

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 3, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)