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

Laparoscopic Surgery Clinical Trial

— TEMP-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294758
• Other study ID #: FPR-IIS -029-02 Ed. 02
• Status: Completed
• Start date: March 2, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Surgery

Locations

Country	Name	City	State
Spain	Hospital la Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of the difference between peritoneal and central temperature during laparoscopic surgery.		Since the beginning until the end of the surgery
Primary	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