Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-25 @ 4:21 AM
Study NCT ID:
NCT02086435
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2014-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069577', 'term': 'Morcellation'}], 'ancestors': [{'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-19', 'studyFirstSubmitDate': '2014-03-09', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'The day of surgery', 'description': "calculated from the time, after secured hemostasis of the uterine breach, in which the myoma is clamped and subjected to intracorporeal or added in endobag for extracorporeal morcellation to the moment when the 'last fragment of myoma will be considered removed from the surgical field"}], 'secondaryOutcomes': [{'measure': 'Total operative time', 'timeFrame': 'The day of surgery', 'description': 'from skin incision to skin closure'}, {'measure': 'Handling of morcellation', 'timeFrame': 'The day of surgery', 'description': 'expressed on the VAS scale where 1 means very bad handling and 10 excellent handling'}, {'measure': 'Blood loss', 'timeFrame': '2 hours after the end of surgery', 'description': 'Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery'}, {'measure': 'Postoperative hospital stay', 'timeFrame': 'The day of patient discharge, average 4 day after surgery'}, {'measure': 'Postoperative pain', 'timeFrame': 'The day of patient discharge, average 4 day after surgery', 'description': 'measured on the VAS scale where 1 stands for a little pain and 10 for intense pain'}, {'measure': 'Rate of complications', 'timeFrame': 'The day of patient discharge, average 4 day after surgery', 'description': 'need of transfusion or laparotomic conversion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myomectomy', 'Laparoscopic myomectomy', 'Morcellation', 'Risk of dissemination', 'Uterine Sarcoma', 'Parasitic myoma'], 'conditions': ['Uterine Myoma']}, 'referencesModule': {'references': [{'pmid': '26801067', 'type': 'DERIVED', 'citation': 'Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications\n* Presence of at least one uterine myoma larger than 4 cm\n* Aged between 18 and 40 years\n\nExclusion Criteria:\n\n* Presence of uterine neoformations suspicious for malignancy\n* Medical major disorders associated\n* Acute or chronic psychiatric disorders\n* Ascertained Premenstrual syndrome\n* Use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment\n* Presence of calcified fibroids ultrasound examination\n* Presence of adnexal lesions\n* Detection of a pattern of endometrial hyperplasia with atypia determined in the course endometrial biopsy performed for abnormal uterine bleeding\n* Abnormal PAP test\n* Positive Pregnancy Test\n* Previous use of laparoscopic surgery increased'}, 'identificationModule': {'nctId': 'NCT02086435', 'acronym': 'IEME', 'briefTitle': 'Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes', 'orgStudyIdInfo': {'id': 'SafeMorcellation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extracorporeal morcellation', 'description': 'Extracorporeal morcellation in which patients are treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself', 'interventionNames': ['Procedure: Extracorporeal morcellation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intracorporeal morcellation', 'description': 'Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device', 'interventionNames': ['Procedure: Intracorporeal morcellation']}], 'interventions': [{'name': 'Extracorporeal morcellation', 'type': 'PROCEDURE', 'otherNames': ['protected morcellation', 'morcellation in endobag'], 'description': 'patients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself', 'armGroupLabels': ['Extracorporeal morcellation']}, {'name': 'Intracorporeal morcellation', 'type': 'PROCEDURE', 'otherNames': ['Power morcellation', 'Standard intracorporeal morcellation'], 'description': 'patients treated with standard intracorporeal morcellation, using reusable electronic device', 'armGroupLabels': ['Intracorporeal morcellation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'state': 'CZ', 'country': 'Italy', 'facility': 'Chair of Obstetrics and Gynecology - University division - UMG', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'overallOfficials': [{'name': 'Fulvio Zullo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Magna Graecia University of Catanzaro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Magna Graecia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor Obstetric Gynecology', 'investigatorFullName': 'Fulvio Zullo', 'investigatorAffiliation': 'University Magna Graecia'}}}}