NCT04294758

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

3.8 years

First QC Date

March 2, 2020

Last Update Submit

April 4, 2024

Conditions

Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing laparoscopic surgery.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital la Fe

Valencia, 46026, Spain

Location

Related Publications (1)

  • 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.

    PMID: 39223302DERIVED

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthetist

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 4, 2020

Study Start

March 2, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations

ES(1)