Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- 24 h Post-operative pain at rest
研究概览
简要总结
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.
详细描述
Breast Cancer (BC) is the leading oncological diagnosis in women with an annual incidence of more than 2 million patients diagnosed every year. Because of growing and ageing of population, by 2040 the BC burden is expected to spread over 3 million new cases and 1 million death every year.
Previous studies have shown that utilizing a conservative approach in breast surgery, followed by radiotherapy, leads to higher overall survival compared to radical mastectomy. In such research, survival with conservative surgery appears to be independent of prognostic factors, tumor characteristics, age, and type of therapy. These findings have paved the way for improvements in patient anaesthesiologic experience, transitioning from general anaesthesia to awake surgery, aiming to reduce the impact of post-operative stress on patient recovery.
Conservative surgery allows for a different anaesthesiologic approach, shifting from general anaesthesia to Monitored Anaesthesia Care (MAC). This form of local anaesthesia, accompanied by sedatives and analgesics dosed to allow spontaneous breathing and airway reflexes, promotes quicker post-operative recovery and less psychological impact on the patient compared to general anaesthesia. A comparison between the two techniques was evaluated using the Quality of Recovery-15 (QoR-15) highlighted a higher score with the use of MAC. Moreover, MAC reduces immunomodulation risk in the early postoperative setting, thus reducing potential long-term oncological outcomes on patients, and promoting a novel less immunosuppressive regimen in frail patients. Several studies in oncological patients demonstrated, in these subsets of patients, that the neoplasm may determine a subclinical impairment of immune response with abnormal response toward non-self or neoplastic cells. In fact, in the era of precision oncology, synergistic effects between drugs, general health status (overweight patients), and BC are investigated to underline the beneficial role of general health measures in long-term outcomes.
Additionally, the COVID-19 pandemic represented a practice-changing accelerator in many healthcare services. Many services tried to gather different procedures in a single hospital admission, to reduce the bed occupancy. Among several innovation, a wider application of telehealth demonstrated that many consultations and healthcare services can be effectively delivered via digital platforms. This approach has the potential not only to improve access to care but also to reduce the environmental impact associated with healthcare practices. Telehealth in the context of breast cancer not only offers advantages in terms of accessibility and continuity of care, but also promotes more sustainable healthcare practices, reducing the environmental impact of medical activities.
Aside from mobility for hospital access, the healthcare industry and hospital facilities contribute to environmental pollution. It was estimated in 2013 that 12% of acid rain, 10% of greenhouse gases (GHG), 10% of smog, 1% of ozone gas depletion, and the production of atmospheric carcinogenic and non-carcinogenic toxins derive from healthcare activities within hospitals, with significant implications for public health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Once enrolled patients were randomized to receive
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients candidates for Breast Conserving Treatment
- •ASA score I-II
- •Availability to Telehealth assessment in the postoperative period
排除标准
- •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
结局指标
主要结局
24 h Post-operative pain at rest
时间窗: 24 hours after surgery
Postoperative Pain at rest with Numeric Pain Rating Scale NPRS (0-10)
24 h Post-operative dynamic pain
时间窗: 24 hours after surgery
Postoperative dynamic Pain with Numeric Pain Rating Scale NPRS (0-10)
次要结局
- Number of hospital admissions after surgery(30 days after surgery)
- Assessment Telehealth implementation(30 days after surgery)
- 48 hours Post-operative pain at rest(30 days hours after surgery)
- 48 hours Post-operative dynamic pain(30 days hours after surgery)
- 30 days Post-operative pain at rest(30 days after surgery)
- 30 days Post-operative dynamic pain(30 days after surgery)
- Carbon footprint of surgery room(Time of surgery)
- Hospitalization(Time of Surgery)
- 30 Days surgical complication(1 months)
- Patients' reported outcome measures(30 days after surgery)
研究者
Gianluca Vanni
Principal Investigator
University of Rome Tor Vergata
