Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06398769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VCare Versus SecuFix Uterine Manipulator for Total Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will be unaware that they will undergo an abdominal hysterectomy using VCare or SecuFix for their surgical procedure.\n\nData entry will utilize a coded system within a pre-designed SPSS spreadsheet. A research assistant, who will be independent of the intervention administration, will enter data for each patient using a designated code (1 or 2) that corresponded to the group assignment. All data will send to an independent statistician for blinded analysis.'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'Operation time was defined as the duration in minutes from the skin incision to detachment of the uterus during surgery.', 'description': 'Operation time was defined as the duration from the skin incision to detachment of the uterus.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uterine manipulator', 'laparoscopy', 'Instruments', 'minimally invasive surgery'], 'conditions': ['Operative Time', 'Length of Hospital Stay', 'Perioperative Complications']}, 'descriptionModule': {'briefSummary': 'Hysterectomy, the most commonly performed gynecological operation, can be carried out through various methods using a wide array of instruments and energy techniques. Minimally invasive procedures such as robotic or laparoscopic approaches are linked to lower perioperative complications and quicker recovery when compared to abdominal hysterectomy. Furthermore, recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries. Uterine manipulation plays a crucial role in laparoscopic hysterectomy by facilitating bladder dissection, positioning the ureters, and exposing the anterior and posterior vaginal fornices. It also prevents pneumoperitoneum loss by closing off the vaginal space. Despite these apparent benefits, there is no existing report comparing different types of uterine manipulators. Therefore, the purpose of this study was to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy based on operative time, length of hospital stay, estimated blood loss, perioperative complications, and subjective performance.', 'detailedDescription': 'Introduction Hysterectomy is the most commonly performed gynecological operation and can be carried out through various methods using a wide array of instruments and energy techniques. Although the methods have advantages and disadvantages over each other, minimally invasive procedures are associated with less morbidity and perioperative recovery. Recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries. Uterine manipulation is crucial in laparoscopic hysterectomy as it facilitates bladder dissection, positioning the ureters, and exposing the anterior and posterior vaginal fornices. It also maintains pneumoperitoneum. Currently, many uterine manipulators are available, but the evidence for their efficacy and safety is still unclear. The purpose of utilizing a uterine manipulator is to enhance surgical outcomes and reduce intraoperative complications, particularly concerning the bladder and ureter. It is important to visualize the anterior and posterior fornices and ensure maintenance of the pneumoperitoneum. Therefore, uterine manipulators play a crucial role in laparoscopic hysterectomy. However, none of the manipulators currently available possess all the characteristics of an ideal manipulator. Therefore, the investigators aimed to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy with regard to operative time, length of hospital stay, estimated blood loss, and perioperative complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 35-65 years\n* hysterectomy for benign gynecological indications\n\nExclusion Criteria:\n\n* history of urogynecologic procedures\n* suspected gynecological malignancy,\n* endometriosis,\n* pelvic inflammatory disease,\n* pelvic organ prolapse,\n* unavailibility of operative records'}, 'identificationModule': {'nctId': 'NCT06398769', 'briefTitle': 'VCare Versus SecuFix Uterine Manipulator for Total Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'Comparison of VCare and SecuFix Uterine Manipulator in Total Laparoscopic Hysterectomy', 'orgStudyIdInfo': {'id': 'uterinemanipulator-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SecuFix UM', 'description': 'SecuFix UM arm: patients undergoing total laparoscopic hysterectomy', 'interventionNames': ['Device: SecuFix UM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VCare UM', 'description': 'VCare UM arm: patients undergoing total laparoscopic hysterectomy', 'interventionNames': ['Device: VCare UM']}], 'interventions': [{'name': 'SecuFix UM', 'type': 'DEVICE', 'description': 'All surgeries were performed using Secufix UM.', 'armGroupLabels': ['SecuFix UM']}, {'name': 'VCare UM', 'type': 'DEVICE', 'description': 'All surgeries were performed using VCare UM.', 'armGroupLabels': ['VCare UM']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The dataset used and/or analyzed in the study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof, MD, PhD candidate', 'investigatorFullName': 'Esra Keles', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}