AzTrials
AzTrials

SustainabilityNCT07457853

Sustainability of Laparoscopic Appendectomy. Variability of Determining Factors.

An observational study of Sustainability, run by Universidad de La Frontera at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Today, evidence shows that environmental changes significantly affect human health. The healthcare sector itself is a major emitter of environmental pollutants. It is responsible for 4-5% of global greenhouse gas emissions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sustainability
How many people
63 participants
Where
1 siteChile
Study dates
30 Aug 2024to 1 Oct 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing laparoscopic surgery in acute appendicitis at the Hospital Dr. Hernán Henríquez Aravena in Temuco, Chile.

Who may be able to join

  • Patients scheduled for laparoscopic surgical interventions for acute appendicitis.
  • Participants must be over 18 years of age, competent, and able to easily understand the informed consent form and the characteristics of the study.
  • Consent to participate

Who cannot join

  • -Other procedures or surgeries.

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Hospital Hernán Henríquez Aravena

    Temuco, Araucania, 4814507

Other trials in Chile

About this study

Today, evidence shows that environmental changes significantly affect human health. The healthcare sector itself is a major emitter of environmental pollutants. It is responsible for 4-5% of global greenhouse gas emissions. The Declaration of Helsinki urges us to protect both human and planetary health, emphasizing the urgency of adopting strategies with a sustainable approach.

Objective: To estimate the sustainability of laparoscopic surgery for acute appendicitis at Dr. Hernán Henríquez Aravena Hospital.

Read more

Methodology: This is a quantitative observational study with a longitudinal analytical design. It will be conducted at Dr. Hernán Henríquez Aravena Hospital in Temuco, Chile. Data will be obtained prospectively through direct collection in the operating room and, when necessary, from the hospital database.

Sustainability is defined in three dimensions. One dimension is economic; therefore, a cost analysis with an operational focus will be conducted. A social dimension will be considered, expressed in the clinical effectiveness of laparoscopic appendectomy in terms of DALYs (Disability-Adjusted Life Years). Finally, the environmental impact of laparoscopic appendectomies will be analyzed. To this end, an environmental impact study will be conducted in accordance with ISO 14040, using the CCALC database and OpenLCA software to estimate CO₂e emissions of greenhouse gases (GHG). The processes and products required to perform each appendectomy will be considered, from the moment the patient enters the operating room until their discharge.

Analysis: Emissions from each surgery will be estimated. Factors such as surgical time, the number of operators involved, and the surgical and anesthetic resources used will be explored. The main result will be the calculation of the Environmental Impact-Effectiveness, considered as the average value. This will generate an indicator expressed in CO₂eq/Euros/average DALYs avoided. This indicator will allow it to describe variability in resource use during interventions, as well as the surgical intervention's carbon footprint and the costs per DALY (Disability-Adjusted Life Year) avoided.

Results: Determination of the sustainability of each surgical procedure and identification of gaps or practices that can improve its sustainability. Development of a matrix of recommendations to improve the clinical sustainability of appendectomies.

Read the detailed description

Evidence shows that changes in our environment negatively affect human health, and the burden of a range of climate-sensitive health problems impacts the functioning of public health systems (1). Paradoxically, the healthcare industry itself is a major emitter of pollutants. Hospital processes generate emissions into the air, water, and soil, producing pharmaceutical, chemical, and radioactive waste that increases risks to human health (2). In the USA, the healthcare sector is responsible for 9-10% of greenhouse gas emissions, which represents 614,000 DALYs (disability-adjusted life years) (2). Today, it is clear that protecting human health without ensuring a healthy environment is counterproductive. The 2020 Helsinki Declaration calls for awareness of the strong interrelationship between human and planetary health (3).

Studying the sustainability of healthcare processes presents an opportunity to mitigate their impact. This is defined as a three-pillar concept encompassing economic, social, and environmental dimensions (4). Information on the environmental impact of a process is derived from a life cycle assessment (LCA), which identifies opportunities to improve environmental performance. To date, LCA studies in healthcare include anesthesia equipment and pharmaceuticals, central venous catheters, dental burs, custom-made disposable surgical packs, surgical instruments, medical-grade plastics, hospital gowns and textiles, and radiology equipment. They also include procedures such as childbirth, hysterectomy, hemodialysis and peritoneal dialysis, plastic surgery, cataract extraction, and intensive care, among others (4-6). However, in our review of the environmental impact of medical procedures, we did not find any sustainability studies that incorporated, in addition to LCA, a clinical effectiveness analysis such as DALYs and an economic evaluation of the intervention.

Operating rooms are the most resource-intensive areas in hospitals, with the three main contributors being energy consumption, anesthesia, and product use (4). Appendectomy is one of the most frequently performed surgeries and is associated with significant morbidity, mortality, and costs. Hospitalizations related to appendicitis cost $3 billion annually in the United States alone (5). Laparoscopic appendectomy offers the greatest benefits, with shorter hospital stays and lower perioperative morbidity (6).

Therefore, this project proposes to conduct a sustainability study of laparoscopic appendectomy. The aim is to determine the variability in resource consumption that defines the carbon footprint of each procedure. Understanding this variability will allow for the identification of gaps or practices that can lead to improved sustainability for each procedure, so that for every year of life lost due to disability or death (DALY) avoided by the procedure, it can be performed at the lowest possible cost and with the least possible environmental impact.

General Objective: To estimate the sustainability of laparoscopic appendectomy procedures performed at the Dr. Hernán Henríquez Aravena Hospital in Temuco (HHHA).

Specific Objectives:

  1. To update costs and estimate environmental damage and its relationship to effectiveness, as DALYs avoided, in order to calculate and describe the behavior of the Cost-Effectiveness-Impact indicator in laparoscopic appendectomy.
  2. To analyze the sustainability of each appendectomy through the Cost-Effectiveness-Environmental Impact indicator, identifying the critical points in their life cycles within the study population.
  3. To estimate the harm to human health, in DALYs, generated by the environmental critical points in the life cycles of laparoscopic appendectomies.

Methodology. Design: Quantitative observational study with a prospective longitudinal analytical design. Accessible population: Patients undergoing laparoscopic surgery for acute appendicitis at the HHHA (Hospital Hermanos Aguilera). Sample size: The sample size was determined using criteria from clinical experts, economists, and administrators, estimating 60 cases. Feasibility and Sampling: The study will be conducted in the operating rooms of the HHHA (Hospital Hernando de Apoquinos), from October 2024 to September 2025, allowing 12 months for case recruitment. At HHHA, 1,213 appendectomies are performed annually. Selection will be systematic, consecutive, and non-probabilistic. A 50% loss to follow-up is expected. Inclusion Criteria: 1) Patients scheduled for laparoscopic surgical interventions for acute appendicitis. 2) Participants must be over 18 years of age, competent, and able to easily understand the informed consent form and the characteristics of the study. Exclusion Criteria: 1) Interventions combined with other procedures or surgeries. Data Collection: A coordinating nurse will select consecutive interventions. They will record clinical and demographic data of the patients after they have signed the informed consent form (attached). The use of supplies will be recorded for each intervention from the moment the patient enters the operating room until they leave (system limit). Data not collected directly (costs) will be extracted from the hospital database.

A/P/S: Laparoscopic Surgery for Acute Appendicitis at HHHA. Functional Unit: This is a single intervention, representative of 60 sample interventions. Reference Flow: The application of a specific intervention to a patient. Scope: The scope will consider inputs from cradle to grave for each intervention performed on the patient in the operating room, defining the entry into the reference flow as the patient's arrival in the operating room until their departure (system boundaries). Allocation: Allocation methods based on physical quantity (mass). Information Sources: Electronic hospital records, patient surveys, and literature. Among other things, the following will be recorded: Mass of surgical and anesthetic supplies, waste and its transport from the hospital to the landfill, recycling, and oxygen and CO2 consumption. Electricity consumption will be quantified during the intervention. The impacts of the production and disposal of disposable clothing, and water consumption, will be measured.

Proposed Analysis:

  1. Economic Analysis: An update and description of the intervention costs will be performed, including marginal, incremental, and average costs. Direct costs will be estimated using micro-costing techniques. Direct healthcare costs of the health technologies used, such as medications, medical devices, and care provided by healthcare professionals, among others, will be measured and quantified. The labor cost of each professional participating in the interventions will be quantified by measuring the number of minutes worked by each. The total cost of each professional's activity will be estimated based on the number of minutes of work performed, multiplied by the monthly remuneration, and divided by the number of minutes worked per month. Obtaining the costs of infrastructure use (electricity, water, heating, operating room time, operating room fees) used in each intervention: Depreciation of equipment and infrastructure will not be included because the study aims to estimate the environmental impact or sustainability of resource use; therefore, energy and/or supplies will be considered. The costing will have an operational focus.
  2. Environmental Impact Analysis: The LCA will be performed using ISO 14040 (2006a) and ISO 14044 (2006b) with the CCALC database and Open LCA software to estimate GHG CO2e emissions. The most significant categories or critical points will be determined, and the resulting damage to human health (DALYs) will be estimated. Life Cycle Inventory: This phase involves compiling and quantifying the inputs and outputs for the given production system throughout its entire life cycle, in order to generate a network of interconnected processes that model the process of each operation. The reference flows will be the basis for calculating each inventory. Electrical energy will be modeled using data from the national electrical grid. Input information will be obtained from the supplier, Ecoinvent, CCALC, or scientific publications. A sensitivity analysis will be performed during the interpretation stage.
  3. Clinical Effectiveness Analysis: The clinical effectiveness measure to be used is the DALYs avoided or prevented, as defined in the disease burden study for appendicitis (7). Information on the average DALYs prevented by surgery will be obtained from this study.

Sustainability Results: After updating costs and estimating critical points of environmental damage, the relationship between both and clinical effectiveness, expressed as average DALYs avoided for the study group, will be analyzed. Thus, the Cost-Effectiveness-Environmental Impact indicator for each surgical intervention will be calculated, considering it as the average value of the Cost-Effectiveness-Environmental Impact ratio. This will yield an indicator expressed in Euro/CO2eq/DALYs avoided. This indicator will describe the variability among surgeries. Variability will be calculated by comparing interventions in the first quartile (low environmental impact) versus those above this quartile. We will be able to identify gaps where sustainability can be improved.

Conditions
Sustainability
Keywords
Cost effectiveness, Life cycle assessment, Burden Disease, Sustainability, Laparoscopic appendicectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustainability of laparoscopic appendectomy

    Sustainability of laparoscopic appendectomy will be calculates with the formula Costs/CO2eq/DALYs avoided. We will calculated the cost associated to laparoscopic appendectomy, the CO2eq and the DALYs avoided.

    Measured: 1 year

Secondary outcomes (3)
  1. Carbon footprint of appendectomy

    Carbon footprint of appendectomy (CO2e)

    Measured: 1 year

  2. Cost

    Average cost per patient and incremental cost.

    Measured: 1 year

  3. Disability-Adjusted Life Years (DALYs) avoided

    Number of healthy years of life saved with laparoscopic appendectomy

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start30 Aug 2024
  3. Primary completion1 Jun 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
63 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457853
Sponsor's protocol ID
DI20-0047
Status last verified
Mar 2026
First submitted
21 Jan 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The full database will be accessible in the publication through a provided link.

Publications

  • Haines A, Ebi K. The Imperative for Climate Action to Protect Health. N Engl J Med. 2019 Jan 17;380(3):263-273. doi: 10.1056/NEJMra1807873. No abstract available.

    PubMed 30650330
  • Eckelman MJ, Sherman JD. Estimated Global Disease Burden From US Health Care Sector Greenhouse Gas Emissions. Am J Public Health. 2018 Apr;108(S2):S120-S122. doi: 10.2105/AJPH.2017.303846. Epub 2017 Oct 26.

    PubMed 29072942
  • Halonen JI, Erhola M, Furman E, Haahtela T, Jousilahti P, Barouki R, Bergman A, Billo NE, Fuller R, Haines A, Kogevinas M, Kolossa-Gehring M, Krauze K, Lanki T, Vicente JL, Messerli P, Nieuwenhuijsen M, Paloniemi R, Peters A, Posch KH, Timonen P, Vermeulen R, Virtanen SM, Bousquet J, Anto JM. A call for urgent action to safeguard our planet and our health in line with the helsinki declaration. Environ Res. 2021 Feb;193:110600. doi: 10.1016/j.envres.2020.110600. Epub 2020 Dec 9.

    PubMed 33307082
  • Seifert C, Koep L, Wolf P, Guenther E. Life cycle assessment as decision support tool for environmental management in hospitals: A literature review. Health Care Manage Rev. 2021 Jan/Mar;46(1):12-24. doi: 10.1097/HMR.0000000000000248.

    PubMed 31116121
  • Sherman JD, Thiel C, MacNeill A, Eckelman MJ, Dubrow R, Hopf H, et al. The Green Print: Advancement of Environmental Sustainability in Healthcare. Resources, Conservation and Recycling. 2020 Vol. 161:1-11. doi: 10.1016/j.resconrec.2020.104882.

  • Parvatker AG, Tunceroglu H, Sherman JD, Coish P, Anastas P, Zimmerman JB, et al. Cradle-to-Gate Greenhouse Gas Emissions for Twenty Anesthetic Active Pharmaceutical Ingredients Based on Process Scale-Up and Process Design Calculations. ACS Sustainable Chemistry and Engineering. 2019 Apr 1;7(7):6580-91.

  • Drew J, Christie SD, Tyedmers P, Smith-Forrester J, Rainham D. Operating in a Climate Crisis: A State-of-the-Science Review of Life Cycle Assessment within Surgical and Anesthetic Care. Environ Health Perspect. 2021 Jul;129(7):76001. doi: 10.1289/EHP8666. Epub 2021 Jul 12.

    PubMed 34251875
  • Ferris M, Quan S, Kaplan BS, Molodecky N, Ball CG, Chernoff GW, Bhala N, Ghosh S, Dixon E, Ng S, Kaplan GG. The Global Incidence of Appendicitis: A Systematic Review of Population-based Studies. Ann Surg. 2017 Aug;266(2):237-241. doi: 10.1097/SLA.0000000000002188.

    PubMed 28288060
  • Jaschinski T, Mosch CG, Eikermann M, Neugebauer EA, Sauerland S. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2018 Nov 28;11(11):CD001546. doi: 10.1002/14651858.CD001546.pub4.

    PubMed 30484855
  • https://www.healthdata.org/research-analysis/gbd.

Questions about this trial

What is this clinical trial studying?

An observational study of Sustainability, run by Universidad de La Frontera at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustainability of laparoscopic appendectomy (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07457853, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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