Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-25 @ 9:07 PM
Study NCT ID:
NCT02829333
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Anesthetic Technique on VEGF-C and PGE2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of vascular endothelial growth factor C before anesthesia and at 48 hours after surgery', 'timeFrame': 'Before anesthesia and at 48 hours after surgery', 'description': 'Blood samples were sampled before anesthesia and at 48h after surgery for the serum VEGF-C，which were analyzed by using enzyme linked immunosorbent assay (ELISA).'}, {'measure': 'Change of prostaglandin E2 before anesthesia and at 48 hours after surgery', 'timeFrame': 'Before anesthesia and at 48 hours after surgery', 'description': 'Blood samples were sampled before anesthesia and at 48h after surgery for the serum PGE2，which were analyzed by using enzyme linked immunosorbent assay (ELISA).'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale (VAS) pain scores', 'timeFrame': 'at 2h, 4h, 8h, 12h, 24h and 48h after surgery', 'description': 'Visual analog scale (VAS) pain scores were used to evaluate postoperative pain at 2h, 4h, 8h, 12h, 24h and 48h after surgery by the anesthetist'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['analgesia', 'anesthesia', 'leiomyomas', 'tumor', 'vascular endothelial growth factor', 'anesthesia technique on tumor'], 'conditions': ['Uterine Leiomyomas']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the effect of anesthetic technique on the change of postoperative serum vascular endothelial growth factor C and prostaglandin E2, and to explore the potential impact of the anesthetic technique on leiomyomas recurrence and growth after the surgery of abdominal myomectomy.', 'detailedDescription': "Uterine leiomyomas is the most common benign tumor of uterus, the most common tumor in women as well. Like many other forms of tumor, it requires an independent blood supply to enlarge. This process, angiogenesis, is mediated by vascular endothelial growth factor C (VEGF-C) and prostaglandin E2 (PGE2). Several studies have confirmed that VEGF-C has a high level in patients with uterine leiomyomas, which has also been demonstrated that it was related to occurrence and growth of uterine leiomyomas because it's capable of promoting angiogenesis, mitogenic, and vascular permeability-enhancing activities. Also, some researchers suggested that suppression of prostaglandin synthesis (including PGE2) via cyclooxygenase type-2 (COX-2) enzyme inhibition may reduce the incidence of some tumor. The aim of this study is to verify the effect of anesthetic technique on the change of postoperative serum VEGF-C and PGE2, and to explore the potential impact of the anesthetic technique on leiomyomas recurrence and growth after the surgery of abdominal myomectomy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with leiomyomas requiring abdominal myomectomy, aged 18-65 year and American Society of Anesthesiologists (ASA) physical status I or II.\n\nExclusion Criteria:\n\n* The patients who had a history of surgery within the preceding two weeks, a history of blood transfusion and a history of coronary artery disease, any contraindication to spinal anesthesia or opioid analgesia.'}, 'identificationModule': {'nctId': 'NCT02829333', 'briefTitle': 'The Effect of Anesthetic Technique on VEGF-C and PGE2', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Effect of Anesthetic Technique on Serum Vascular Endothelial Growth Factor C and Prostaglandin E2 in Women Undergoing Surgery for Uterine Leiomyomas', 'orgStudyIdInfo': {'id': 'Zhangyonghai001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group GA', 'description': '22 patients receive general anesthesia and patient controlled intravenous analgesia', 'interventionNames': ['Other: general anesthesia and patient controlled intravenous analgesia']}, {'type': 'OTHER', 'label': 'Group SA', 'description': '22 patients receive spinal anesthesia and continuous postoperative epidural analgesia', 'interventionNames': ['Other: spinal anesthesia and continuous postoperative epidural analgesia']}], 'interventions': [{'name': 'general anesthesia and patient controlled intravenous analgesia', 'type': 'OTHER', 'description': 'Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation', 'armGroupLabels': ['Group GA']}, {'name': 'spinal anesthesia and continuous postoperative epidural analgesia', 'type': 'OTHER', 'description': 'Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation', 'armGroupLabels': ['Group SA']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}