Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-11 @ 12:35 PM
Study NCT ID:
NCT02747550
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2016-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009214', 'term': 'Myoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709632', 'term': 'testo'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2016-04-19', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative blood loss', 'timeFrame': 'the day of surgery', 'description': 'Operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.'}], 'secondaryOutcomes': [{'measure': 'change in hemoglobin', 'timeFrame': 'post-operative day 1', 'description': 'The change in hemoglobin change was defined as the difference between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.', 'detailedDescription': 'Significant hemorrhage is major perioperative concern in myomectomy, and can result in need of blood transfusion, conversion to hysterectomy, development of hypovolemic shock and postoperative anemia, and delayed recovery. Therefore, methods to decrease operative blood loss during myomectomy in women wishing to preserve their uterus and fertility are important and must be developed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with symptomatic myomas such as menorrhagia, pelvic pressure/pain, or infertility\n* women who were planning to undergo laparoscopic myomectomy\n* women who had ≤ 10 myomas, with the largest myoma ≤ 10 cm\n* women with regular menstrual bleeding\n* women who were not pregnant at the surgery\n* women between 19 and 48 years of age.\n\nExclusion Criteria:\n\n* women who underwent concomitant complex surgical procedures at the time of laparoscopic myomectomy, such as severe adhesiolysis or resection for severe endometriosis\n* women who were in postmenopausal or climacteric status\n* women with a history of oophorectomy or salpingo-oophorectomy\n* women with any suggestion of malignant uterine or adnexal diseases\n* women with major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance\n* women who refused to participate or give consent to the procedures'}, 'identificationModule': {'nctId': 'NCT02747550', 'acronym': 'TESTO', 'briefTitle': 'Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Temporary Simultaneous Two-arterial Occlusions to Reduce Operative Blood Loss During Laparoscopic Myomectomy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2016-04-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LM with TESTO', 'description': 'In subjects allocated to the experimental group, the temporary simultaneous two-arterial occlusions (TESTO) procedure was performed to minimize operative blood loss during laparoscopic myomectomy.', 'interventionNames': ['Procedure: LM with TESTO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LM without TESTO', 'description': 'In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy.', 'interventionNames': ['Procedure: LM without TESTO']}], 'interventions': [{'name': 'LM with TESTO', 'type': 'PROCEDURE', 'description': 'In subjects allocated to the experimental group, the temporary simultaneous two-arterial occlusions (TESTO) procedure was performed to minimize operative blood loss during laparoscopic myomectomy.', 'armGroupLabels': ['LM with TESTO']}, {'name': 'LM without TESTO', 'type': 'PROCEDURE', 'description': 'In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy', 'armGroupLabels': ['LM without TESTO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-746', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Taejong Song, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangbuk Samsung Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Taejong Song', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}