Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT04687527
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-13', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preoperative Vitamin D Level and postoperative pain in patients to undergo laparoscopic cholecystectomy operation', 'timeFrame': '6 months', 'description': 'Correlations of preoperative Vitamin D Level between postoperative pain in patients undergoing laparoscopic cholecystectomy.to undergo laparoscopic cholecystectomy operation'}], 'secondaryOutcomes': [{'measure': 'preoperative Vitamin D Level and opioid analgesic consumption', 'timeFrame': '6 months', 'description': 'Correlations of preoperative Vitamin D Level between opioid analgesic consumption in patients undergoing laparoscopic cholecystectomy.to undergo laparoscopic cholecystectomy operation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic cholecystectomy', 'Vitamin D Deficiency', 'Postoperative Pain'], 'conditions': ['Vitamin D Deficiency', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The deficiency of vitamin D is common in patients with gastrointestinal system disorders.\n\nVitamin D has been associated with chronic non-specific musculoskeletal pain and migraines due to anti-inflammatory effects.\n\nThis prospective observational study will undergo elective laparoscopic cholecystectomy surgery between 18 and 65 years, is planned to participate in ASA (American Society of Anesthesiologists) 1-3, 90 volunteer patients.\n\nIn preoperative evaluation, the remaining 3 ml of blood was centrifuged from the routine received blood to determine the level of vitamin D will be kept.\n\nPostoperative will be applied to patient controlled analgesia to all patients for 24 hours.\n\nTo determine the level of postoperative pain, the visual analog scale (VAS) will be used in the clock unit and at the service 6, 12 and 24 hours.\n\nIn this study, the investigators aimed to test the hypothesis of relation to pain and opioid consumption in acute postoperative (24 hours) of perioperative low-vitamin D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteer patients undergoing elective laparoscopic cholecystectomy surgery by the Department of General Surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer,\n* Between the Ages Of 18-65,\n* Least Primary School Graduate,\n* Not Using Drugs That May Affect Cognitive Functions,\n* Non-Alcohol Substance Use,\n* Patients Without Psychiatric and Neurological Disease.\n\nExclusion Criteria:\n\n* Those with known psychiatric disease and drugs,\n* Those with an important cardiovascular or central nervous system disease,\n* Patients with pain syndromes or routinely using opioid.\n\nVery urgent patients'}, 'identificationModule': {'nctId': 'NCT04687527', 'briefTitle': 'Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Bozok University'}, 'officialTitle': 'Effect of Vitamin D Levels on Postoperative Pain and Narcotic Analgesia in Patients With Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '189_2020.03.25_02'}}, 'contactsLocationsModule': {'locations': [{'city': 'Yozgat', 'country': 'Turkey (Türkiye)', 'facility': 'Bozok University Medical Center', 'geoPoint': {'lat': 39.82, 'lon': 34.80444}}], 'overallOfficials': [{'name': 'Ökkeş Hakan Miniksar, Asist.Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'YOZGAT BOZOK UNIVERSITY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bozok University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ökkeş Hakan Miniksar', 'investigatorAffiliation': 'Bozok University'}}}}