Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT04156932
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2019-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closure of the Uterine Artery at Its Origin vs at the Cervix: a Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'estimated blood loss', 'timeFrame': 'End of surgical procedure', 'description': 'ml'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anatomy', 'Laparoscopy', 'Uterine Artery', 'Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '26264829', 'type': 'RESULT', 'citation': 'Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.'}, {'pmid': '22024265', 'type': 'RESULT', 'citation': 'Aust T, Reyftmann L, Rosen D, Cario G, Chou D. Anterior approach to laparoscopic uterine artery ligation. J Minim Invasive Gynecol. 2011 Nov-Dec;18(6):792-5. doi: 10.1016/j.jmig.2011.07.008.'}, {'pmid': '9589145', 'type': 'RESULT', 'citation': 'Simpson NA, Nimrod C, De Vermette R, Leblanc C, Fournier J. Sonographic evaluation of intervillous flow in early pregnancy: use of echo-enhancement agents. Ultrasound Obstet Gynecol. 1998 Mar;11(3):204-8. doi: 10.1046/j.1469-0705.1998.11030204.x.'}, {'pmid': '25839384', 'type': 'RESULT', 'citation': 'Uccella S, Cromi A, Casarin J, Bogani G, Serati M, Gisone B, Pinelli C, Fasola M, Ghezzi F. Minilaparoscopic versus standard laparoscopic hysterectomy for uteri >/= 16 weeks of gestation: surgical outcomes, postoperative quality of life, and cosmesis. J Laparoendosc Adv Surg Tech A. 2015 May;25(5):386-91. doi: 10.1089/lap.2014.0478. Epub 2015 Apr 3.'}, {'pmid': '24012921', 'type': 'RESULT', 'citation': 'Uccella S, Cromi A, Serati M, Casarin J, Sturla D, Ghezzi F. Laparoscopic hysterectomy in case of uteri weighing >/=1 kilogram: a series of 71 cases and review of the literature. J Minim Invasive Gynecol. 2014 May-Jun;21(3):460-5. doi: 10.1016/j.jmig.2013.08.706. Epub 2013 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'One of the fundamental surgical steps in patients undergoing laparoscopic hysterectomy is the closure of the uterine artery, this vessel provides the greatest blood supply to the uterus.\n\nThis step can be done in two ways: the surgeon can choose to interrupt the blood flow by closing the uterine artery in its last part, close to the uterus, or the surgeon can develop the anatomical spaces around the uterus into the deep pelvis, closing it to its origin, maintaining a minimally invasive approach in both cases.\n\nScientific research has tried to establish whether one of the two modalities is the best in reducing intraoperative blood loss and possible complications, but currently there is not enough evidence to recommend an approach rather than another.\n\nThe investigator has therefore decided to evaluate the results at the end of a laparoscopic hysterectomy in a scientifically rigorous manner.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* benign disease\n* elective laparoscopic hysterectomy\n\nExclusion Criteria:\n\n* malignant disease\n* emergency laparoscopic hysterectomy'}, 'identificationModule': {'nctId': 'NCT04156932', 'briefTitle': 'Closure of the Uterine Artery at Its Origin vs at the Cervix: a Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale degli Infermi di Biella'}, 'officialTitle': 'Closure at the Origin of the Uterine Artery vs. Closure at the Cervico-isthmic Level in Laparoscopic Hysterectomy: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '440/CE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OUC', 'description': 'Origin uterine artery closure', 'interventionNames': ['Procedure: uterine artery closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IUC', 'description': 'Cervical-isthmic uterine artery closure', 'interventionNames': ['Procedure: uterine artery closure']}], 'interventions': [{'name': 'uterine artery closure', 'type': 'PROCEDURE', 'description': 'Interruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin.', 'armGroupLabels': ['IUC', 'OUC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13875', 'city': 'Ponderano', 'state': 'Biella', 'country': 'Italy', 'facility': 'Ospedale degli Infermi', 'geoPoint': {'lat': 45.53846, 'lon': 8.05592}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale degli Infermi di Biella', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}