Trial Title:
Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol
NCT ID:
NCT06624917
Condition:
Breast Cancer Female
Breast Cancer
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Neoplasm
Environment Related Outcome Measure
Patients' Reported Outcome Measure
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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).
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Once enrolled patients were randomized to receive
Intervention:
Intervention type:
Procedure
Intervention name:
Green Breast Surgery Protocol
Description:
A perioperative protocol aiming at reducing environmental impact of surgery, and fast
recovery protocol to reduce hospitalization.
Arm group label:
Green Breast Surgery
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.
Detailed description:
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.
The increase in air pollution and consequently the risk of mortality has led to greater
attention to new surgical protocols, which prioritize environmental needs in addition to
patient clinical needs due to the resurgence of advanced-stage breast pathology,
reduction of operating spaces, and dedicated hospitalization for individual patients.
Hospitals and operating rooms represent the primary source of greenhouse gas emissions,
with 25-30% of hospital waste being produced by operating rooms.
Due to significant pollutant emissions, hospitals are a major source of environmental
impact. In England, the National Health Service (NHS) alone is responsible for emitting
18 million tons of CO2, equivalent to 30% of greenhouse gas emissions from the entire
public sector. Therefore, the NHS has initiated reflections and initiatives to make the
healthcare sector carbon neutral. Four different intervention phases have been
identified, highlighting that reducing CO2 emissions in hospitals, especially in
operating rooms, is not simple, mainly due to the current absence of specific guidelines
aimed at gas reduction 20. Evaluation parameters, feasibility, and safety have been
introduced, expressing percentages at various points from a multicenter study that
considers both physicians' and patients' opinions.
A large portion of hospital greenhouse gas emissions comes from the operating room,
primarily due to the use of volatile anaesthetics for general anaesthesia. Among these,
sevoflurane and desflurane are the main pollutants, from their production in the
pharmaceutical sector to their impact on the atmospheric environment, where they persist
for several years (1.4 and 21.4, respectively). These compounds act as greenhouse gases,
contributing to global warming. Additionally, many volatile anaesthetics contain nitrous
oxide (N2O) as a carrier gas, which has a greater impact on global warming when mixed
with ambient air 23. This complex process, from pharmaceutical production to the
atmosphere, represents a significant source of greenhouse gases originating from the
hospital setting.
It has been shown that reducing the use of anaesthetics, especially the volatile ones, in
surgery is possible, particularly highlighted by Wide-Awake Local Anaesthesia
No-Tourniquet (WALANT) surgery performed for small ambulatory hand operations. Patient
satisfaction and better resource allocation are the most significant post-operative
benefits of WALANT. Studies have reported that 94% of patients would choose WALANT again
in the future. Patients experience reduced post-operative pain compared to previous
surgeries with tourniquet sedation. WALANT promotes better communication between the
patient and the surgical team, enhancing understanding, compliance, and prevention of
post-operative injuries. It reduces time spent in the post-operative phase, resulting in
decreased costs for both the facility and the patient.
Reducing surgical impact has been a recent theme in general surgery. Since the 2000s,
numerous authors have begun outlining the so-called Enhanced Recovery After Surgery
(ERAS) protocols in general surgery, especially in colorectal surgery 26,27. This
multidisciplinary protocol aims to improve outcomes after surgery, articulating into four
phases to ensure better control and greater adherence to the correct course:
pre-hospitalization, pre-operative, intra-operative, and post-operative. Regarding
colorectal surgery, ERAS programs have shown improvements in post-operative
hospitalization times, mortality, and consequently increased long-term survival.
Specifically, in patients with ≥70% adherence to the ERAS protocol, the 5-year specific
cancer death risk decreased by 42%.
From the results of studies conducted using ERAS and WALANT approaches, as well as
telehealth assistance, it has emerged that their protocols can be effectively applied in
breast surgery. In fact, in the recent years, awake surgery plus locoregional anesthetic
regimen emerged as novel approach to accelerate postoperative recovery and minimize
postoperative complication. Consequently, our group is committed to implementing such
studies and evaluating the results obtained.
The ERAS protocol can also be applied in the field of breast surgery, which, together
with telehealth in the peri-operative and post-operative pathways, lays the groundwork
for the Green Breast Surgery research project. This pathway is dedicated to patients
undergoing conservative surgical treatment for breast pathology and is based on the
analysis of clinical outcomes, quality of life, as well as social, environmental, and
economic effects in the application of this telehealth protocol in clinical practice.
Limiting the resources applied in operating rooms allows for a greater number of patients
to undergo surgical procedures, particularly in the field of senology. The reason why the
Breast Unit is a good candidate for this type of protocol lies in the possibility of
operating on the patient while awake, without the need for general anaesthesia, due to
the simplicity of the surgical procedure itself.
A recent study has highlighted how climate change exacerbates health problems and creates
new ones, particularly in low-income countries. Among the effects of climate change,
increasing temperatures lead to a higher frequency of surgical site infections by up to
39%, while air pollution causes prolonged hospital stays and increased costs. A protocol
has been implemented with five different aspects of the surgical setting that can be
improved, ranging from the use of non-volatile anaesthetics to modifying some behaviors
of operating room staff such as reducing the use of syringes, turning off lights when the
operating room is not in use, and implementing telehealth instead of outpatient visits.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Università degli Studi di Roma Tor Vergata
Address:
City:
Roma
Zip:
00133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Oreste Claudio Buonomo, Full Professor
Phone:
06209088350
Email:
o.buonomo@inwind.it
Contact backup:
Last name:
Marco Materazzo, MD
Phone:
3395685883
Email:
marco.materazzo@ptvonline.it
Investigator:
Last name:
Oreste Claudio Buonomo, Full Professor
Email:
Principal Investigator
Investigator:
Last name:
Marco Materazzo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Marco Pellicciaro, MD
Email:
Sub-Investigator
Start date:
July 1, 2024
Completion date:
January 1, 2025
Lead sponsor:
Agency:
University of Rome Tor Vergata
Agency class:
Other
Source:
University of Rome Tor Vergata
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06624917
