Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study (TEMP-19)

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Hospital la Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic surgery.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimation of the difference between peritoneal and central temperature during laparoscopic surgery.	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.	Since the beginning until the end of the surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FPR-IIS -029-02 Ed. 02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No