Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02709460
Status:
UNKNOWN
Last Update Posted:
2019-03-13
First Post:
2016-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D006406', 'term': 'Hematoma'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of postoperative hematoma', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hematoma', 'complication', 'hysterectomy'], 'conditions': ['Postoperative Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Laparoscopic hysterectomy is associated with complications in form of infections and subsequently dehiscence of the vault. This is a serious complication. The infection may be related to the frequently observed postoperative hematoma following traditional laparoscopic hysterectomy where the uterine artery is coagulated and divided at the cervical entry into the uterus.\n\nBy coagulation of the uterine artery laterally close to the internal iliac artery this problem may be eliminated due to the much less bleeding observed during this procedure.', 'detailedDescription': 'Laparoscopic hysterectomy (removal of the uterus) is today a well-described method for the removal of the uterus. The operation is offered in case of bleeding disorders where other treatments have been unsuccessful, uterine fibroids or other conditions requiring surgery with removal of the uterus.\n\nThe operation is done today in most cases by dividing the uterine artery at the entrance to the cervix, where the artery divides into one ascending and descending branch.\n\nThe most common complication of hysterectomy is bleeding perioperative well as postoperatively, which may result in a hematoma above the vaginal vault.\n\nThrough the years different methods have been tried to reduce this complication, including tranexamic acid without great success. The hematoma may result in infection postoperative and subsequent poor healing, with the possibility of dehiscence of the vault.\n\nIn the worst case, the gut is displaced through the vagina postoperatively. This condition can lead to diffuse peritonitis, which can be fatal in rare cases.\n\nSince the hemostasis related to the dividing of the artery uterine can be problematic, especially in case of fibroids it may be a technical advantage to coagulate the Uterine artery at the exit of the Internal Iliac artery. This operation also ensures identification of the ureter, which can be spared. Lesions to the ureter are detected in up to 1% of all surgical procedures at hysterectomy.\n\nDividing of the Uterine artery at the Internal Iliac Artery also ensures that the artery can be divided with minimal bleeding at the cervix.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women submitted to total laparoscopic hysterectomy\n\nExclusion Criteria:\n\n* Women \\<18 years\n* Women no able to understand the study or not native in Danish\n* Women with uterine malignancy\n* Women with suspicion of pelvic mass\n* Women with abnormal coagulation\n* Women receiving glucocorticoid treatment\n* Women receiving anticoagulant treatment or have not followed prescription in relation to surgery'}, 'identificationModule': {'nctId': 'NCT02709460', 'briefTitle': 'Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Lateral Versus Cervical Coagulation of the Uterine Artery in Benign Hysterectomy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'S-20140104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lateral occlusion', 'description': 'Women included in this arm is randomized to lateral occlusion of the uterine artery', 'interventionNames': ['Procedure: Lateral occlusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cervical occlusion', 'description': 'Women included in this arm is randomized to occlusion of the uterine artery at cervical entry', 'interventionNames': ['Procedure: Cervical occlusion']}], 'interventions': [{'name': 'Lateral occlusion', 'type': 'PROCEDURE', 'description': 'Lateral occlusion close to the internal Iliac artery', 'armGroupLabels': ['Lateral occlusion']}, {'name': 'Cervical occlusion', 'type': 'PROCEDURE', 'description': 'Cervical occlusion of the uterine artery', 'armGroupLabels': ['cervical occlusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Martin Rudnicki, Professor', 'role': 'CONTACT', 'email': 'mr@rsyd.dk', 'phone': '+45 60113333'}, {'name': 'Vibeke Lysdal, Consultant', 'role': 'CONTACT', 'phone': '+4560113333'}], 'facility': 'Vibeke Lysdal', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Vibeke Lysdal, Consultant', 'role': 'CONTACT', 'email': 'mr@rsyd.dk', 'phone': '+4560113333'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Vibeke Lysdal', 'investigatorAffiliation': 'Odense University Hospital'}}}}