Clinical trial · Interventional
Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Green Breast Surgery Protocol | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Green Breast Surgery
- description
- 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.
- interventionNames
- Procedure: Green Breast Surgery Protocol
- type
- NO_INTERVENTION
- label
- Conventional Surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients candidates for Breast Conserving Treatment * ASA score I-II * Availability to Telehealth assessment in the postoperative period Exclusion Criteria: * 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
References
Publications (3)
- BACKGROUNDMaterazzo 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
- BACKGROUNDVanni 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
- BACKGROUNDVanni 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