Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT06776718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2024-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VNOTES and Vaginal Hysterectomy for Benign Indications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007045', 'term': 'Hysterectomy, Vaginal'}], 'ancestors': [{'id': 'D007044', 'term': 'Hysterectomy'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2024-12-24', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the duration of surgery', 'timeFrame': 'The time from the beginning to the end of the operation', 'description': 'İnterval from initial incision to the completion of vaginal cuff closure (minute)'}], 'secondaryOutcomes': [{'measure': 'Hospitalization time', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Time from surgery to discharge (hours)'}, {'measure': 'VAS score', 'timeFrame': 'postoperative 6th and 24 th hour', 'description': 'Visual Analog Score for pain at postoperative 6th and 24 th hour (0-10)'}, {'measure': 'Uterin volume', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Uterine volume is quantified in milimeters based on measurement of pathological specimens, calculate using the formula (Uterine volume (ml)= (anterior-posterior diameter)\\* (sagital diameter) \\* (transverse diameter) \\* 0,0005236'}, {'measure': 'Re-admission', 'timeFrame': 'within 1 month after discharge', 'description': 'Re-admission to hospital after discharge (yes/no)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vNOTES', 'vaginal hysterectomy', 'benign gynecology', 'surgical outcomes', 'Pain'], 'conditions': ['Hysterectomy', 'Hysterectomy, Benign Uterine Diseases', 'Hysterectomy, Vaginal']}, 'referencesModule': {'references': [{'pmid': '39084252', 'type': 'BACKGROUND', 'citation': 'Yildiz P, Keles E, Yildiz G, Birol Ilter P, Temocin RB, Kaya C, Mat E. Health-related quality of life following hysterectomy by vNOTES versus conventional laparoscopy. Minim Invasive Ther Allied Technol. 2024 Aug;33(4):232-236. doi: 10.1080/13645706.2024.2323100. Epub 2024 Mar 4.'}, {'pmid': '35074513', 'type': 'BACKGROUND', 'citation': 'Merlier M, Collinet P, Pierache A, Vandendriessche D, Delporte V, Rubod C, Cosson M, Giraudet G. Is V-NOTES Hysterectomy as Safe and Feasible as Outpatient Surgery Compared with Vaginal Hysterectomy? J Minim Invasive Gynecol. 2022 May;29(5):665-672. doi: 10.1016/j.jmig.2022.01.007. Epub 2022 Jan 21.'}, {'pmid': '30325565', 'type': 'BACKGROUND', 'citation': 'Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol B, Bosteels J. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.'}, {'pmid': '37642285', 'type': 'BACKGROUND', 'citation': 'Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions.\n\nA prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Patients aged 40-80 who underwent hysterectomy for benign indications will included. Outcomes will assessed included surgical outcomes, Visual Analog Scale (VAS) pain scores, and complication rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 40 and 80 years\n* undergo hysterectomy for benign gynecological conditions\n\nExclusion Criteria:\n\n* history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),\n* suspected gynecologic malignancies,\n* endometriosis,\n* tubal-ovarian abscesses,\n* pelvic organ prolapse exceeding grade 2,\n* individuals who refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT06776718', 'briefTitle': 'VNOTES and Vaginal Hysterectomy for Benign Indications', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications', 'orgStudyIdInfo': {'id': '2021/514/214/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vNOTES hysterectomy for benign indications', 'interventionNames': ['Procedure: vNOTES']}, {'type': 'EXPERIMENTAL', 'label': 'Vaginal hysterectomy for benign indications', 'interventionNames': ['Procedure: vaginal hysterectomy']}], 'interventions': [{'name': 'vNOTES', 'type': 'PROCEDURE', 'description': 'vNOTES for benign hysterectomy', 'armGroupLabels': ['vNOTES hysterectomy for benign indications']}, {'name': 'vaginal hysterectomy', 'type': 'PROCEDURE', 'description': 'vaginal hysterectomy for benign hysterectomy', 'armGroupLabels': ['Vaginal hysterectomy for benign indications']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34865', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kartal Dr. Lütfi Kırdar Şehir Hastanesi', 'role': 'CONTACT', 'email': 'istkartal.sh@saglik.gov.tr', 'phone': '+902164413900'}, {'name': 'Gazi Yıldız, Assoc Prof', 'role': 'CONTACT'}, {'name': 'Pınar Yıldız, MD', 'role': 'CONTACT'}, {'name': 'Esra Keleş, Assoc Prof', 'role': 'CONTACT'}, {'name': 'Pınar Birol İlter, MD', 'role': 'CONTACT'}, {'name': 'Kasım Turan, MD', 'role': 'CONTACT'}, {'name': 'Emre Mat, Assoc Prof', 'role': 'CONTACT'}, {'name': 'Mehmet Mete Kırlangıç, Assoc Prof', 'role': 'CONTACT'}], 'facility': 'Kartal Dr Lütfi Kirdar City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Gazi Yıldız, Assoc Prof', 'role': 'CONTACT', 'email': 'drgaziyildiz@gmail.com', 'phone': '+905535288666'}, {'name': 'Mehmet Mete Kırlangıç, Assoc Prof', 'role': 'CONTACT', 'email': 'metekirlangic@gmail.com', 'phone': '+905064641819'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Mehmet Mete Kırlangıç', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}