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Completed

NCT Number: NCT04294758

Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study

Estimation of the difference between the temperature of the peritoneal microenvironment and the central body temperature during laparoscopic surgery. Prospective observational study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital la Fe

Valencia, 46026, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Pregnancy or breastfeeding.
  • Refusal of the patient to participate in the study.

Treatment and study plan

Primary outcomes

  1. Estimation of the difference between peritoneal and central temperature during laparoscopic surgery.

    Time frame: Since the beginning until the end of the surgery

  2. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Acronym: TEMP-19

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2020
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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