Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-26 @ 2:29 PM
Study NCT ID:
NCT06776068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Lumboscopy Versus Laparoscopy on Ventilatory Mechanics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parameters of ventilatory mechanics', 'timeFrame': 'intraoperative', 'description': 'Static compliance Plateau pressure Driving pressure Transpulmonary pressure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Lumboscopy', 'Mechanical Ventilation', 'Laparoscopy'], 'conditions': ['Anesthesia', 'Mechanical Ventilation', 'Respiratory Physiology']}, 'referencesModule': {'references': [{'pmid': '8740033', 'type': 'BACKGROUND', 'citation': 'Guillonneau B, Ballanger P, Lugagne PM, Valla JS, Vallancien G. Laparoscopic versus lumboscopic nephrectomy. Eur Urol. 1996;29(3):288-91. doi: 10.1159/000473762.'}]}, 'descriptionModule': {'briefSummary': 'There are several techniques for performing minimally invasive urological surgeries. Among them, laparoscopic surgery, robotic surgery, and lumboscopy are noteworthy (1). The medical literature extensively documents the impact of pneumoperitoneum a procedure involving the insufflation of the peritoneal cavity with carbon dioxide (CO2), which is essential for laparoscopic and robotic surgeries on ventilatory mechanics.\n\nAs an alternative, CO2 insufflation into the retroperitoneum, as utilized in lumboscopic surgery, has been proposed. This approach is believed to exert a lesser impact on respiratory function and pulmonary mechanics. However, it is important to note that no conclusive evidence has yet been found to support this claim.\n\nAssessing the impact of lumboscopic surgery could help establish it as a viable alternative for patients with pulmonary conditions, where mechanical ventilation poses significant challenges. To explore this possibility, a physiological study was designed to compare the effects of laparoscopic and lumboscopic surgery on ventilatory mechanics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing general anesthesia for minimally invasive nephrectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years old\n* ASA PS II-III\n* Elective surgery\n* Surgery: Partial or total nephrectomy\n\nExclusion Criteria:\n\n* Severe pulmonary pathology\n* Severe cardiovascular pathology\n* Open surgery'}, 'identificationModule': {'nctId': 'NCT06776068', 'briefTitle': 'The Impact of Lumboscopy Versus Laparoscopy on Ventilatory Mechanics', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Comparison of the Impact of Lumboscopy and Laparoscopy on Ventilatory Mechanics in Patients Undergoing Nephrectomy', 'orgStudyIdInfo': {'id': 'CR/23053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients undergoing general anesthesia for laparoscopic and lumboscopic nephrectomy', 'description': 'Adult patients undergoing general anesthesia for laparoscopic and lumboscopic nephrectomy.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'contacts': [{'name': 'Roberto González, MD', 'role': 'CONTACT', 'email': 'robgonzalez@uchile.cl', 'phone': '+56999397515'}, {'name': 'Felipe Maldonado, MD', 'role': 'CONTACT', 'email': 'felitech@gmail.com', 'phone': '+56992160831'}], 'facility': 'Hospital Clínico Universidad de CHile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'contacts': [{'name': 'Roberto González, MD', 'role': 'CONTACT', 'email': 'robgonzalez@uchile.cl', 'phone': '+56999397515'}, {'name': 'Nicolás Valls, PhD, MD', 'role': 'CONTACT', 'email': 'nicolas.valls@incancer.cl', 'phone': '+56933741332'}], 'facility': 'Instituto Nacional del Cáncer', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Roberto González, MD', 'role': 'CONTACT', 'email': 'robgonzalez@uchile.cl', 'phone': '+56999397515'}, {'name': 'Felipe Maldonado, MD', 'role': 'CONTACT', 'email': 'felitech@gmail.com', 'phone': '+56992160831'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Roberto Gonzalez Cornejo', 'investigatorAffiliation': 'University of Chile'}}}}