Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT04519593
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'At the end of the intervention', 'description': 'Evaluation of blood loss volume'}], 'secondaryOutcomes': [{'measure': 'Treatment characteristics', 'timeFrame': 'During 6 months since the intervention', 'description': 'Rates of intra- and postoperative complications, necessity of blood transfusion, length of surgery, length of hospital and ICU stay, leiomyoma symptoms relief'}, {'measure': 'Impact on fertility', 'timeFrame': 'During 18 months since the intervention', 'description': 'Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['temporary uterine artery occlusion', 'temporary uterine blood supply occlusion'], 'conditions': ['Uterine Leiomyoma', 'Uterine Fibroid', 'Leiomyoma, Uterine', 'Myoma;Uterus', 'Laparoscopic Myomectomy', 'Postoperative Complications', 'Blood Loss, Surgical', 'Fertility Issues', 'Pregnancy Complications']}, 'descriptionModule': {'briefSummary': 'A phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.', 'detailedDescription': 'Primary endpoints\n\n• Assess the volume of blood loss\n\nSecondary endpoints\n\n* Compare the rates of intra- and postoperative complications, the necessity of blood transfusion, length of surgery, length of hospital and ICU stay, and leiomyoma symptoms relief\n* Determine the procedure impact on fertility by evaluating the level of anti-mullerian hormone, pregnancy rates, pregnancy complications, and the way of delivery\n\nPatients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach.\n\nSixty patients will undergo laparoscopic myomectomy preceded by temporary uterine blood supply occlusion performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study. Sixty patients will undergo conventional laparoscopic myomectomy performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study.\n\nPatients eligible for inclusion, after signing an informed voluntary consent to participate in the study, will be randomized in a 1:1 ratio to the treatment groups using stratification by age, size, and leiomyoma nodes location.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic uterine leiomyoma\n* Size of leiomyoma node \\>5 cm based on imaging\n* Leiomyoma node types 3, 4, 5, 6 according to The International Federation of Gynecology and Obstetrics (FIGO) classification or type 2 not feasible to be removed during hysteroscopy\n* Single or multiple nodes\n* Absent contraindications for laparoscopic myomectomy\n* Voluntarily signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Asymptomatic uterine leiomyoma\n* Size of leiomyoma node \\<5 cm based on imaging\n* Absence of leiomyoma node types 3, 4, 5, 6 according to FIGO classification and type 2 not feasible to be removed during hysteroscopy\n* Planned simultaneous hysteroscopy with leiomyoma node excision\n* Current pregnancy and breastfeeding\n* Suspicion of a malignant uterine tumor\n* Prior uterine leiomyoma surgery\n* Contraindications for laparoscopic myomectomy\n* Lack of decision-making capacity hindering signing the consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT04519593', 'briefTitle': 'ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma', 'organization': {'class': 'OTHER', 'fullName': 'Mother and Child Clinic Saint-Petersburg'}, 'officialTitle': 'ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma', 'orgStudyIdInfo': {'id': 'MCCSPb-8-12-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic myomectomy with temporary blood supply occlusion', 'description': 'Laparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.', 'interventionNames': ['Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional laparoscopic myomectomy', 'description': 'Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.', 'interventionNames': ['Procedure: Conventional laparoscopic myomectomy']}], 'interventions': [{'name': 'Laparoscopic myomectomy with prior temporary uterine blood supply occlusion', 'type': 'PROCEDURE', 'otherNames': ['Temporary uterine arteries occlusion'], 'description': 'Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.', 'armGroupLabels': ['Laparoscopic myomectomy with temporary blood supply occlusion']}, {'name': 'Conventional laparoscopic myomectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic myomectomy without prior temporary uterine blood supply occlusion', 'armGroupLabels': ['Conventional laparoscopic myomectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '199106', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Andrei Dubinin, MD, PhD', 'role': 'CONTACT', 'email': 'andub@mail.ru', 'phone': '+79811506112'}, {'name': 'Andrei Dubinin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pavel Sorokin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mother and Child Clinic Saint-Petersburg', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Andrei Dubinin, MD, PhD', 'role': 'CONTACT', 'email': 'andub@mail.ru', 'phone': '+79811506112'}, {'name': 'Pavel Sorokin, MD', 'role': 'CONTACT', 'email': 'sor-pavel@ya.ru', 'phone': '+79835218691'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mother and Child Clinic Saint-Petersburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecologist', 'investigatorFullName': 'Andrey Dubinin, MD, PhD', 'investigatorAffiliation': 'Mother and Child Clinic Saint-Petersburg'}}}}