Laparoscopic SurgeryTEMP-19NCT04294758
Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study
An observational study of Laparoscopic Surgery, run by Hospital Universitario La Fe at 1 site in Spain.
Trial summary
Estimation of the difference between the temperature of the peritoneal microenvironment and the central body temperature during laparoscopic surgery. Prospective observational study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing laparoscopic surgery.
Who may be able to join
- Patients older than 18 years.
- Classification of the American Society of Anesthesiologists (ASA I-III).
- Patients who do not have cognitive deficits.
- Prior signed informed consent.
Who cannot join
- Pregnancy or breastfeeding.
- Refusal of the patient to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Estimation of the difference between the temperature of the peritoneal microenvironment and the central body temperature during laparoscopic surgery. Prospective observational study.
Read the detailed description
Prospective unblinded observational study to measure the difference between central and peritoneal temperature during laparoscopic surgery.
CO2 insufflation at the peritoneal level to generate the pneumoperitoneum necessary to perform laparoscopic surgery results in a decrease in peritoneal temperature greater than that generated at the central level (esophageal temperature).
The potential long-term advantages of maintaining normothermia at the peritoneal level during laparoscopic surgery may derive from the reversal of the harmful effects of hypothermia at the level of the peritoneal microenvironment since the regional hypoxia resulting from vasoconstriction and the inhibition of functionality cellular that can favor complications such as bleeding or suture dehiscence.
On the other hand, the immune system can be affected by regional hypothermia in several ways. First, postoperative vasoconstriction restricts metabolic heat to the central regions of the body and accelerates overheating, but can simultaneously reduce tissue perfusion by inhibiting oxidative destruction of neutrophils, which is the first line of defense against bacterial contamination. Second, hypothermia reduces systemic immunity and decreases macrophage motility. Third, hypothermia reduces the recovery capacity necessary for wound contamination.
- Conditions
- Laparoscopic Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the difference between peritoneal and central temperature during laparoscopic surgery.
Measured: Since the beginning until the end of the surgery
Assess the difference between peritoneal and central temperature during laparoscopic surgery is modified with the total amount of insufflated gas and / or the duration of surgery.
Measured: Since the beginning until the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start2 Mar 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- 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
- 51 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294758
- Sponsor's protocol ID
- FPR-IIS -029-02 Ed. 02
- Acronym
- TEMP-19
- Status last verified
- Apr 2024
- First submitted
- 2 Mar 2020
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mazzinari G, Rovira L, Vila Montanes M, Garcia Gregorio N, Ayas Montero B, Alberola Estelles MJ, Flor B, Argente Navarro MP, Diaz-Cambronero O. Estimation of the difference between peritoneal microenvironment and core body temperature during laparoscopic surgery - a prospective observational study. Sci Rep. 2024 Sep 2;14(1):20408. doi: 10.1038/s41598-024-71611-z.
PubMed 39223302
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04294758
- Acronym / sponsor ID
- TEMP-19 / FPR-IIS -029-02 Ed. 02
- Conditions
- Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Mar 2020 (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.
Estimation of the difference between the temperature of the peritoneal microenvironment and the central body temperature during laparoscopic surgery. Prospective observational study.
Detailed description
Prospective unblinded observational study to measure the difference between central and peritoneal temperature during laparoscopic surgery.
CO2 insufflation at the peritoneal level to generate the pneumoperitoneum necessary to perform laparoscopic surgery results in a decrease in peritoneal temperature greater than that generated at the central level (esophageal temperature).
The potential long-term advantages of maintaining normothermia at the peritoneal level during laparoscopic surgery may derive from the reversal of the harmful effects of hypothermia at the level of the peritoneal microenvironment since the regional hypoxia resulting from vasoconstriction and the inhibition of functionality cellular that can favor complications such as bleeding or suture dehiscence.
On the other hand, the immune system can be affected by regional hypothermia in several ways. First, postoperative vasoconstriction restricts metabolic heat to the central regions of the body and accelerates overheating, but can simultaneously reduce tissue perfusion by inhibiting oxidative destruction of neutrophils, which is the first line of defense against bacterial contamination. Second, hypothermia reduces systemic immunity and decreases macrophage motility. Third, hypothermia reduces the recovery capacity necessary for wound contamination.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic surgery.
Key inclusion criteria (4 listed)
- Patients older than 18 years.
- Classification of the American Society of Anesthesiologists (ASA I-III).
- Patients who do not have cognitive deficits.
- Prior signed informed consent.
Key exclusion criteria (2 listed)
- Pregnancy or breastfeeding.
- Refusal of the patient to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimation of the difference between peritoneal and central temperature during laparoscopic surgery.
Time frame: Since the beginning until the end of the surgery
Assess the difference between peritoneal and central temperature during laparoscopic surgery is modified with the total amount of insufflated gas and / or the duration of surgery.
Time frame: Since the beginning until the end of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 39223302Mazzinari G, Rovira L, Vila Montanes M, Garcia Gregorio N, Ayas Montero B, Alberola Estelles MJ, Flor B, Argente Navarro MP, Diaz-Cambronero O. Estimation of the difference between peritoneal microenvironment and core body temperature during laparoscopic surgery - a prospective observational study. Sci Rep. 2024 Sep 2;14(1):20408. doi: 10.1038/s41598-024-71611-z.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgery, run by Hospital Universitario La Fe at 1 site in Spain.
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 4 inclusion and 2 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 5 Apr 2024. 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 Spain. 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?
Estimation of the difference between peritoneal and central temperature during laparoscopic surgery. (time frame: Since the beginning until the end of the surgery). The study lists 2 primary outcomes in all. 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 NCT04294758, which also lists 1 linked publication.
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 5 Apr 2024.