Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT06209034
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2024-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Single(Participant)'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-01-06', 'studyFirstSubmitQcDate': '2024-01-06', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of optic nerve sheath diameter', 'timeFrame': 'During the operation', 'description': 'Ultrasound measurement of optic nerve sheath diameter during laparoscopic surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonography', 'Optic nerve sheath diameter', 'Laparoscopic surgery'], 'conditions': ['Optic Nerve Sheath Diameter', 'Intracranial Pressure Increase']}, 'descriptionModule': {'briefSummary': 'Laparoscopic surgery is a widely used alternative to open surgery; Advantages include reduced bleeding and pain intensity, shorter hospital stay, and improved cosmetic results.\n\nLaparoscopic surgery involves the creation of a carbon dioxide (CO2) pneumoperitoneum to facilitate a clear surgical view, which can result in increased intracranial pressure (ICP).\n\nUltrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment.Ultrasonographic assessment of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive measurement of intracranial pressure.', 'detailedDescription': 'Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment. Previous studies have demonstrated that ultrasonographic measurement of ONSD correlates with the degree of ICP and can detect intracranial hypertension in a variety of clinical settings.\n\nIt was planned to measure the optic nerve sheath throughout the surgery with the help of a linear ultrasound probe.\n\nUltrasonographically, in each measurement, the optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes. ONSD will be measured bilaterally 3 mm behind the papilla. It will be evaluated by transverse measurement for each optic nerve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 aged patients\n* American Society of Anesthesiologists Classification (ASA) I-II-III patients\n* Patients undergoing laparoscopic surgery\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists Classification (ASA) IV-V patients\n* Those with known ophthalmic disease\n* Those with a history of ophthalmic surgery\n* Those with any known neurological disorder\n* History of intracranial hypertension\n* Patients who will undergo open abdominal surgery'}, 'identificationModule': {'nctId': 'NCT06209034', 'briefTitle': 'Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Ultrasonographic Evaluation of Intraoperative Optic Nerve Sheath Diameter Changes in Patients Undergoing Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'KÜ GOKAEK-2023/19.12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Optic nerve sheath measurement', 'description': 'Optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes in each ultrasonographic measurement. ONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve.', 'interventionNames': ['Other: Optic nerve sheath measurement']}], 'interventions': [{'name': 'Optic nerve sheath measurement', 'type': 'OTHER', 'description': 'ONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve.', 'armGroupLabels': ['Optic nerve sheath measurement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}, {'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Sevim Cesur', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Sevim Cesur', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kocaeli University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Sevim Cesur', 'investigatorAffiliation': 'Kocaeli University'}}}}