Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT06750003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
4K Versus 3D Total Laparoscopic Bilateral Oophorectomy: Tools in Comparison
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010049', 'term': 'Ovarian Diseases'}], 'ancestors': [{'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-15', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'from enrollment to the end of follow up at 12 months', 'description': 'To compare the operative time of bilateral oophorectomy performed using 3D laparoscopy versus 4K laparoscopy for benign indications, conducted by trainee surgeons.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benign ovarian disease', 'laparoscopy', 'annessiectomy', 'ovariectomy', 'resident', 'tridimensional', 'high definition surgery', '3D', '4K'], 'conditions': ['Ovarian Diseases']}, 'descriptionModule': {'briefSummary': 'Evaluate whether the 4K laparoscopic vision system can provide an advantage in performing bilateral oophorectomy procedures for benign conditions carried out by trainee surgeons compared to 3D laparoscopy', 'detailedDescription': 'All patients diagnosed with suspected benign ovarian pathology based on preoperative examinations (pelvic Doppler ultrasound and/or magnetic resonance imaging and/or CT scan) and with indication for bilateral laparoscopic adnexectomy will be enrolled in the study. The primary objective of the study is to compare surgical times between the 3D and 4K vision systems in laparoscopic ovarian surgery, specifically in bilateral adnexectomy performed by trainee surgeons. Secondary objectives will include evaluating intra- and postoperative complications, length of hospital stay, and costs to the healthcare system'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with benign ovarian pathology requiring bilateral oophorectomy\n* ASA score \\<3\n* Patients who have signed the appropriate informed consent\n* Patients who are not pregnant or diagnosed with pelvic inflammatory disease\n* No history of prior major abdominal surgery\n\nExclusion Criteria:\n\n* Suspected neoplastic pathology\n* Patients not eligible for surgery'}, 'identificationModule': {'nctId': 'NCT06750003', 'acronym': 'TOLSTOY', 'briefTitle': '4K Versus 3D Total Laparoscopic Bilateral Oophorectomy: Tools in Comparison', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria-Universitaria Integrata di Udine'}, 'officialTitle': '4K Versus 3D Total Laparoscopic Bilateral Oophorectomy by Surgeons in Training: Tools in Comparison', 'orgStudyIdInfo': {'id': '33935'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '3D laparoscopy', 'description': 'Performed using 3D laparoscopy', 'interventionNames': ['Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy']}, {'type': 'EXPERIMENTAL', 'label': '4K laparoscopy', 'description': 'Performed using 4K laparoscopy', 'interventionNames': ['Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy']}], 'interventions': [{'name': '3D versus 4K laparoscopic bilateral salpingo-oophorectomy', 'type': 'PROCEDURE', 'description': '3D laparoscopy versus 4K laparoscopy for bilateral salpingo-oophorectomy performed by residents', 'armGroupLabels': ['3D laparoscopy', '4K laparoscopy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MD, Graduation', 'role': 'CONTACT', 'email': 'stefano.restaino@asufc.sanita.fvg.it', 'phone': '0432 559695'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria-Universitaria Integrata di Udine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Stefano Restaino', 'investigatorAffiliation': 'Azienda Sanitaria-Universitaria Integrata di Udine'}}}}