Colorectal OperationsCARENCT06844604
Carbon Footprint Assessment for Robotic, Laparoscopic and Open Colorectal Operations to Enhance Environmental Sustainability
An observational study of Colorectal Operations, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
The goal of this study is to conduct a life cycle assessment of robotic, laparoscopic and open colorectal procedures and compare their climate impact. Further the investigators want to identify major targets for possible reduction in the CO2 footprint in colorectal procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Operations
- What is being tested?
- robotic colorectal procedures, laparoscopic colorectal procedures and open colorectal procedures
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 19 Mar 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from primary care units that are in need of a colorectal surgery and fulfil the inclusion criteria.
Who may be able to join
- Elective operations which are routinely performed robot-assisted, laparoscopic and open:
- Only Colorectal procedures involving a bowel resection will be included (colectomies (right/left), anterior resections)
- General anesthesia
- Aged > 18 years
- ASA classification from I to III
Who cannot join
- Procedures, which were uncompleted due to complications
- Procedures, which switched modality (laparoscopic to open, robot-assisted to open)
- Emergency procedures (mainly laparoscopic, unforeseen risk factors that lead to a change of modality, higher volume of used compressions and other materials).
- Aged younger than 18
- ASA classification > III
- Vulnerable patient groups (pregnancy, patients with mental disability)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Clarunis
Basel, 4031
Marco von Strauss und Torney, +41 61 777 75 81, marco.vonstrauss@clarunis.ch
- Recruiting
University Hospital of Basel
Basel, 4031
About this study
Official title: Life Cylce Assessment (LCA) for Different Minimal Invasive Surgical Techniques: A Comparison of Robotic vs . Laparoscopic vs Open Colorectal Operation and Identification of Most Effective Carbon Foot Print Reduction Targets.
The goal of this study is to conduct a life cycle assessment of robotic, laparoscopic and open colorectal procedures and compare their climate impact. Further the investigators want to identify major targets for possible reduction in the CO2 footprint in colorectal procedures. The main questions are:
Researchers will identify used and prepared materials and instruments for the individual procedures and weigh them individually. SimaPro databases will help calculate the carbon footprints for the used instruments. Additionally, energy waste will be measured and carbon footprint of anesthesia will be estimated with previous existing data from other studies.
Read the detailed description
Background Effective reduction of greenhouse gas (GHG) emissions as the key driver for climate change has to be the primary target of sustainable economics in the 21st century . The carbon footprint is calculated by the direct and indirect attributable GHGs emitted during a process, production cycle, or from an institution, such as a hospital.[1] The main metric for calculating the carbon footprint is the CO2 equivalent (CO2eq). In Switzerland, about 6-7% of all CO2 emissions come from the healthcare system. Most CO2 emissions come from hospitals, followed by medical treatments.
A large contributor to hospitals' carbon footprints are operating rooms. The high energy demand, anesthetics, and the production of single-use devices and instruments are significant climate-related hotspots in the operating field. However, the life cycle assessment (LCA) varies considerably based on factors such as the type and modality of the operation, among other variables. To date, only a few direct comparisons of the climate impact between surgical modalities, such as open, laparoscopic, and robot-assisted procedures, have been studied.
In this study, the investigators aim to compare the three modalities of visceral operations and their impact on the carbon footprint. As previously mentioned, a major component of the high GHG production in operating rooms is the high energy demand and needed resources. The best method to calculate the climate impact is the use of LCA.
Within an LCA, climate-related hotspots can be identified for each operation analyzed, which can provide possible ideas to reduce the carbon footprint of operating rooms and their impact on climate change.
Methods For this comparison, the investigators will conduct an LCA for each operation observed and compare it among the three different modalities: robotic, laparoscopic and open colorectal procedures.
The LCA includes direct and indirect GHG emissions throughout a product's lifetime, as well as energy consumption during the operation. This encompasses the raw materials used, emissions during production and transportation, and the accumulated waste. A life cycle inventory (LCI) collects LCAs for all instruments and products used during the procedure and during preparation.
Used surgical instruments, drapes, gloves and gowns will be registered in the prefabricated datasheet during the observed colorectal operation. Single-use equipment recorded in the datasheet will be weighed individually before usage. During the procedure the investigators will then identify not used and used materials and instruments. Their packaging will be weighed after the operation to differentiate between packaging and absolute weight of used instrument. Using the manufacturer's information about raw material usage in each product, the investigators will calculate the CO2 footprint of the individual instruments and materials. In the Ecoinvent database with recorded CO2 emissions per kilogram of raw material will provide the necessary information to conduct LCAs for each product used in the operating room. This study will include sterile as well as non-sterile equipment used during preparing and performing the procedure. For reusable instruments, the investigators will estimate the total CO2 footprint, including the sterilization process, using average values from previous studies. Reusable instruments used for robotic operations is estimated to have a life span of around 10 to 15 sterilization processes. The estimated life cycle for laparoscopic reusable instruments is set to be around 100 sterilization processes. Other reusable surgical instruments that are commonly used are estimated to live up to 1000 sterilization cycles.
During the procedures the investigators will identify the majority of not used but prepared instruments. Additionally to the materials and instruments the investigators will record the used anesthetics for general anesthesia and with previous study calculate the estimated climate impact For the secondary research question the investigators will differentiate between used, opened and prepared equipment in the operating room during the procedure. The research team will therefore additionally identify material and instruments that were unpacked but not used during the procedures It is important to state, that only used and opened instruments and materials will be included in the calculation of the CO2 footprint.
To calculate the energy used during the operations, the kilowatt hours (kWh) needed during the procedure itself will be extracted as average energy consumption in the operating room where the surgery took place. The investigators will then calculate the CO2 footprint using information about the clinic's energy mix. Additionally, the research team will use standardized calculations for the CO2 footprint of anesthesia and hospital stay to estimate the value for the observed operations.
The raw data will be collected in an REDCAP database and further analyzed with the software SimaPro or OpenLCA. The investigators then estimate the related CO2 footprint per procedure. The mean CO2 footprint will afterwards be used to compare the three modality. For comparisons between groups, the research team will use the Mann-Whitney U test in R and RStudio. Climate impact will be estimated using the ReCiPe method.
Target The aim of the LCA robotic operation study is to compare the carbon footprint between robotic, laparoscopic and open colorectal procedures and to identify major targets for the reduction of CO2 emissions.
- Conditions
- Colorectal Operations
- Being tested
- robotic colorectal procedures, laparoscopic colorectal procedures, open colorectal procedures
- Keywords
- colorectal operations, CO2 footprint, LCA, robotic colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic colorectal proceduresProcedure or surgery
any colorectal procedure planed robot-assisted
laparoscopic colorectal proceduresProcedure or surgery
any colorectal procedure planed laparoscopically
open colorectal proceduresProcedure or surgery
any colorectal procedure planed open
| Study group | Role | What they receive |
|---|---|---|
| robotic colorectal procedures | Not described Receives: Procedure: robotic colorectal procedures | |
| laparoscopic colorectal procedures | Not described Receives: Procedure: laparoscopic colorectal procedures | |
| open colorectal procedures | Not described Receives: Procedure: open colorectal procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of climate impact between robotic, laparoscopic and open colorectal procedures
Conduct an analysis of the climate impact of the three modalities of modern visceral operation and the standardized hospital days after the observed surgeries using LCA and the ReCiPe method. Compare the three modalities.
Measured: 9 monts
Secondary outcomes (1)
Identify major targets for possible reduction in the CO2 footprint in visceral procedures.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start19 Mar 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal OperationsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844604
- Sponsor's protocol ID
- CARE25
- Acronym
- CARE
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2025
- Last updated
- 14 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huijbregts Mark A.J., Steinmann Zoran J.N., Eishout Pieter M. F., Stam Gea, Verones Francesca, ReCiPe2016: a harmonised life cycle impact assessment method at midpoint and endpoint level, The international Journal of Life Cycle Assessment, 02.01.2017
Misrai V, Rijo E, Cottenceau JB, Zorn KC, Enikeev D, Elterman D, Bhojani N, De La Taille A, Herrmann TRW, Robert G, Pradere B. A Standardized Method for Estimating the Carbon Footprint of Disposable Minimally Invasive Surgical Devices: Application in Transurethral Prostate Surgery. Ann Surg Open. 2021 Sep 7;2(3):e094. doi: 10.1097/AS9.0000000000000094. eCollection 2021 Sep.
PubMed 37635829Woods DL, McAndrew T, Nevadunsky N, Hou JY, Goldberg G, Yi-Shin Kuo D, Isani S. Carbon footprint of robotically-assisted laparoscopy, laparoscopy and laparotomy: a comparison. Int J Med Robot. 2015 Dec;11(4):406-12. doi: 10.1002/rcs.1640. Epub 2015 Feb 22.
PubMed 25708320Sapuan S.M., Ilyas R. A., Asyraf M. R. M., Carbon footprint in Healthcare, Springer, 2022
Rodriguez-Jimenez L, Romero-Martin M, Spruell T, Steley Z, Gomez-Salgado J. The carbon footprint of healthcare settings: A systematic review. J Adv Nurs. 2023 Aug;79(8):2830-2844. doi: 10.1111/jan.15671. Epub 2023 May 17.
PubMed 37198974swissinfo.ch, health system causes too high CO2 emissions, says top Swiss doctor, SWI swissinfo.ch, 10.27.2023
Wiedmann Thomas, Minx Jan, A definition of carbon footprint, Nova science Publishers, 2007
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Cylce Assessment (LCA) for Different Minimal Invasive Surgical Techniques: A Comparison of Robotic vs . Laparoscopic vs Open Colorectal Operation and Identification of Most Effective Carbon Foot Print Reduction Targets.
- ClinicalTrials.gov ID
- NCT06844604
- Acronym / sponsor ID
- CARE / CARE25
- Conditions
- Colorectal Operations
- Keywords
- colorectal operations, CO2 footprint, LCA, robotic colorectal surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to conduct a life cycle assessment of robotic, laparoscopic and open colorectal procedures and compare their climate impact. Further the investigators want to identify major targets for possible reduction in the CO2 footprint in colorectal procedures. The main questions are:
Researchers will identify used and prepared materials and instruments for the individual procedures and weigh them individually. SimaPro databases will help calculate the carbon footprints for the used instruments. Additionally, energy waste will be measured and carbon footprint of anesthesia will be estimated with previous existing data from other studies.
Detailed description
Background Effective reduction of greenhouse gas (GHG) emissions as the key driver for climate change has to be the primary target of sustainable economics in the 21st century . The carbon footprint is calculated by the direct and indirect attributable GHGs emitted during a process, production cycle, or from an institution, such as a hospital.[1] The main metric for calculating the carbon footprint is the CO2 equivalent (CO2eq). In Switzerland, about 6-7% of all CO2 emissions come from the healthcare system. Most CO2 emissions come from hospitals, followed by medical treatments.
A large contributor to hospitals' carbon footprints are operating rooms. The high energy demand, anesthetics, and the production of single-use devices and instruments are significant climate-related hotspots in the operating field. However, the life cycle assessment (LCA) varies considerably based on factors such as the type and modality of the operation, among other variables. To date, only a few direct comparisons of the climate impact between surgical modalities, such as open, laparoscopic, and robot-assisted procedures, have been studied.
In this study, the investigators aim to compare the three modalities of visceral operations and their impact on the carbon footprint. As previously mentioned, a major component of the high GHG production in operating rooms is the high energy demand and needed resources. The best method to calculate the climate impact is the use of LCA.
Within an LCA, climate-related hotspots can be identified for each operation analyzed, which can provide possible ideas to reduce the carbon footprint of operating rooms and their impact on climate change.
Methods For this comparison, the investigators will conduct an LCA for each operation observed and compare it among the three different modalities: robotic, laparoscopic and open colorectal procedures.
The LCA includes direct and indirect GHG emissions throughout a product's lifetime, as well as energy consumption during the operation. This encompasses the raw materials used, emissions during production and transportation, and the accumulated waste. A life cycle inventory (LCI) collects LCAs for all instruments and products used during the procedure and during preparation.
Used surgical instruments, drapes, gloves and gowns will be registered in the prefabricated datasheet during the observed colorectal operation. Single-use equipment recorded in the datasheet will be weighed individually before usage. During the procedure the investigators will then identify not used and used materials and instruments. Their packaging will be weighed after the operation to differentiate between packaging and absolute weight of used instrument. Using the manufacturer's information about raw material usage in each product, the investigators will calculate the CO2 footprint of the individual instruments and materials. In the Ecoinvent database with recorded CO2 emissions per kilogram of raw material will provide the necessary information to conduct LCAs for each product used in the operating room. This study will include sterile as well as non-sterile equipment used during preparing and performing the procedure. For reusable instruments, the investigators will estimate the total CO2 footprint, including the sterilization process, using average values from previous studies. Reusable instruments used for robotic operations is estimated to have a life span of around 10 to 15 sterilization processes. The estimated life cycle for laparoscopic reusable instruments is set to be around 100 sterilization processes. Other reusable surgical instruments that are commonly used are estimated to live up to 1000 sterilization cycles.
During the procedures the investigators will identify the majority of not used but prepared instruments. Additionally to the materials and instruments the investigators will record the used anesthetics for general anesthesia and with previous study calculate the estimated climate impact For the secondary research question the investigators will differentiate between used, opened and prepared equipment in the operating room during the procedure. The research team will therefore additionally identify material and instruments that were unpacked but not used during the procedures It is important to state, that only used and opened instruments and materials will be included in the calculation of the CO2 footprint.
To calculate the energy used during the operations, the kilowatt hours (kWh) needed during the procedure itself will be extracted as average energy consumption in the operating room where the surgery took place. The investigators will then calculate the CO2 footprint using information about the clinic's energy mix. Additionally, the research team will use standardized calculations for the CO2 footprint of anesthesia and hospital stay to estimate the value for the observed operations.
The raw data will be collected in an REDCAP database and further analyzed with the software SimaPro or OpenLCA. The investigators then estimate the related CO2 footprint per procedure. The mean CO2 footprint will afterwards be used to compare the three modality. For comparisons between groups, the research team will use the Mann-Whitney U test in R and RStudio. Climate impact will be estimated using the ReCiPe method.
Target The aim of the LCA robotic operation study is to compare the carbon footprint between robotic, laparoscopic and open colorectal procedures and to identify major targets for the reduction of CO2 emissions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| robotic colorectal procedures | – | Procedure: robotic colorectal procedures |
| laparoscopic colorectal procedures | – | Procedure: laparoscopic colorectal procedures |
| open colorectal procedures | – | Procedure: open colorectal procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from primary care units that are in need of a colorectal surgery and fulfil the inclusion criteria.
Key inclusion criteria (5 listed)
- Elective operations which are routinely performed robot-assisted, laparoscopic and open:
- General anesthesia
- Aged > 18 years
- ASA classification from I to III
Key exclusion criteria (6 listed)
- Procedures, which were uncompleted due to complications
- Procedures, which switched modality (laparoscopic to open, robot-assisted to open)
- Emergency procedures (mainly laparoscopic, unforeseen risk factors that lead to a change of modality, higher volume of used compressions and other materials).
- Aged younger than 18
- ASA classification > III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic colorectal proceduresany colorectal procedure planed robot-assisted | Procedure or surgery | robotic colorectal procedures |
| laparoscopic colorectal proceduresany colorectal procedure planed laparoscopically | Procedure or surgery | laparoscopic colorectal procedures |
| open colorectal proceduresany colorectal procedure planed open | Procedure or surgery | open colorectal procedures |
Primary outcome
Comparison of climate impact between robotic, laparoscopic and open colorectal procedures
Time frame: 9 monts
Conduct an analysis of the climate impact of the three modalities of modern visceral operation and the standardized hospital days after the observed surgeries using LCA and the ReCiPe method. Compare the three modalities.
1 secondary outcome
Identify major targets for possible reduction in the CO2 footprint in visceral procedures.
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2025.
- BackgroundHuijbregts Mark A.J., Steinmann Zoran J.N., Eishout Pieter M. F., Stam Gea, Verones Francesca, ReCiPe2016: a harmonised life cycle impact assessment method at midpoint and endpoint level, The international Journal of Life Cycle Assessment, 02.01.2017
- Background: PubMed 37635829Misrai V, Rijo E, Cottenceau JB, Zorn KC, Enikeev D, Elterman D, Bhojani N, De La Taille A, Herrmann TRW, Robert G, Pradere B. A Standardized Method for Estimating the Carbon Footprint of Disposable Minimally Invasive Surgical Devices: Application in Transurethral Prostate Surgery. Ann Surg Open. 2021 Sep 7;2(3):e094. doi: 10.1097/AS9.0000000000000094. eCollection 2021 Sep.
- Background: PubMed 25708320Woods DL, McAndrew T, Nevadunsky N, Hou JY, Goldberg G, Yi-Shin Kuo D, Isani S. Carbon footprint of robotically-assisted laparoscopy, laparoscopy and laparotomy: a comparison. Int J Med Robot. 2015 Dec;11(4):406-12. doi: 10.1002/rcs.1640. Epub 2015 Feb 22.
- BackgroundSapuan S.M., Ilyas R. A., Asyraf M. R. M., Carbon footprint in Healthcare, Springer, 2022
- Background: PubMed 37198974Rodriguez-Jimenez L, Romero-Martin M, Spruell T, Steley Z, Gomez-Salgado J. The carbon footprint of healthcare settings: A systematic review. J Adv Nurs. 2023 Aug;79(8):2830-2844. doi: 10.1111/jan.15671. Epub 2023 May 17.
- Backgroundswissinfo.ch, health system causes too high CO2 emissions, says top Swiss doctor, SWI swissinfo.ch, 10.27.2023
- BackgroundWiedmann Thomas, Minx Jan, A definition of carbon footprint, Nova science Publishers, 2007
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Operations, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco von Strauss und Torney, PD Dr. med. (+41 61 777 75 81, marco.vonstrauss@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of climate impact between robotic, laparoscopic and open colorectal procedures (time frame: 9 monts). 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 NCT06844604, which also lists 7 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 14 Apr 2025.