Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT06014203
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examination of Edema After Arthroscopic Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edema', 'timeFrame': '3 months', 'description': 'After the MoistureMeterD Compact local edema measuring device is placed perpendicular to the area to be measured, it will be held for 3 seconds and the percent moisture value will be recorded. 3 measurements will be made for each region. The average of the 3 measurements will be used in the statistical analysis.'}], 'secondaryOutcomes': [{'measure': 'Surgery time', 'timeFrame': '3 months', 'description': 'The duration of each operation will be recorded in minutes by the surgeon performing the operation.'}, {'measure': 'Amount of the saline', 'timeFrame': '3 months', 'description': 'The amount of saline fluid used in each operation will be recorded in liters by the surgeon performing the operation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Edema', 'Shoulder arthroscopy'], 'conditions': ['Edema', 'Arthroscopy', 'Shoulder']}, 'referencesModule': {'references': [{'pmid': '39814377', 'type': 'DERIVED', 'citation': 'Ayas IH, Akcan YO, Haspolat M, Tokgoz MA, Keser I, Kanatli U. Subcutaneous Pectoral Edema After Arthroscopic Labral Repair Despite Normal Irrigation Fluid Usage and Surgery Duration. Orthop Surg. 2025 Feb;17(2):624-630. doi: 10.1111/os.14324. Epub 2025 Jan 15.'}]}, 'descriptionModule': {'briefSummary': "The investigators's aim is to examine trunk and upper extremity edema after arthroscopic rotator cuff repair and/or labrum repair surgeries. During surgery, the shoulder joint capsule is cut and the joint is entered arthroscopically. During this procedure, approximately 3-6 liters of saline fluid is injected into the joint, depending on the duration of the surgery. The given fluid accumulates out of the joint in relation to the duration of the surgery and the amount of fluid given. In this study, the investigators aim is to examine how much the extra-articular fluid collects under the skin of the upper extremity and trunk, and the change in the amount of fluid 24 hours after surgery. Examination of the amount of subcutaneous fluid may help to better understand the postoperative complications such as edema, carpal tunnel syndrome, compartment syndrome, myolysis, and dyspnea. How much edema the joint and surrounding structures are exposed to and its relationship with the duration of surgery can help to clinicians determine the safe discharge time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for arthroscopic shoulder surgery in Gazi University Hospital, Department of Orthopedics and Traumatology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arthroscopic shoulder surgery planned\n* 18-65 years old\n\nExclusion Criteria:\n\n* Frozen/stiff shoulder\n* Metabolic and endocrine diseases\n* Dermatological pathologies\n* Hyperlaxity'}, 'identificationModule': {'nctId': 'NCT06014203', 'briefTitle': 'Examination of Edema After Arthroscopic Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Examination of Edema After Arthroscopic Shoulder Surgery', 'orgStudyIdInfo': {'id': 'Iayas5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing shoulder arthroscopy surgery', 'description': 'Patients who underwent arthroscopic shoulder surgery by a single surgeon at Gazi Hospital Department of Orthopedics and Traumatology (rotator cuff repair, slap, bankart repair)', 'interventionNames': ['Diagnostic Test: Edema measurement']}], 'interventions': [{'name': 'Edema measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subcutaneous fluid measurements will be made 3 times in total, before the surgery, immediately after the surgery and 24 hours after the surgery. Measurements will be made with the MoistureMeterD Compact local edema measuring device.\n\nPoints to be measured:\n\n1. Midpoint of the upper trapezius muscle\n2. 5 cm distal to anterior acromion\n3. 5cm distal to lateral acromion\n4. 5cm distal to posterior acromion\n5. 3cm medial to the axilla\n6. Anterior cubital fossa\n7. Carpal tunnel', 'armGroupLabels': ['Patients undergoing shoulder arthroscopy surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'İnci H Ayas, MSc', 'role': 'CONTACT', 'email': 'inciayass@gmail.com', 'phone': '(0312) 216 26 01'}], 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'İnci H Ayas', 'role': 'CONTACT', 'email': 'inciayass@gmail.com', 'phone': '05071740342'}], 'overallOfficials': [{'name': 'Ulunay Kanatlı', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'İnci Hazal Ayas', 'investigatorAffiliation': 'Gazi University'}}}}