Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-01-24 @ 10:02 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of the difference between peritoneal and central temperature during laparoscopic surgery.', 'timeFrame': 'Since the beginning until the end of the surgery'}, {'measure': '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.', 'timeFrame': 'Since the beginning until the end of the surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Surgery']}, 'referencesModule': {'references': [{'pmid': '39223302', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Estimation of the difference between the temperature of the peritoneal microenvironment and the central body temperature during laparoscopic surgery. Prospective observational study.', 'detailedDescription': 'Prospective unblinded observational study to measure the difference between central and peritoneal temperature during laparoscopic surgery.\n\nCO2 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).\n\nThe 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.\n\nOn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing laparoscopic surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years.\n* Classification of the American Society of Anesthesiologists (ASA I-III).\n* Patients who do not have cognitive deficits.\n* Prior signed informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Refusal of the patient to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04294758', 'acronym': 'TEMP-19', 'briefTitle': 'Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Fe'}, 'officialTitle': 'Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study', 'orgStudyIdInfo': {'id': 'FPR-IIS -029-02 Ed. 02'}}, 'contactsLocationsModule': {'locations': [{'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Fe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthetist', 'investigatorFullName': 'Oscar Diaz-Cambronero', 'investigatorAffiliation': 'Hospital Universitario La Fe'}}}}