Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 8:02 PM
Study NCT ID:
NCT04294758
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2020-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study
Sponsor:
Hospital Universitario La Fe
Organization:
Study Overview
Official Title:
Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEMP-19
Brief Summary:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: