Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-06-26 @ 5:11 AM
Study NCT ID:
NCT03281460
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2017-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of In-bag Morcellation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007044', 'term': 'Hysterectomy'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smooth muscular cells in the peritoneal fluid after morcellation', 'timeFrame': 'Day 0 - just after surgery', 'description': 'After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum'}], 'secondaryOutcomes': [{'measure': 'duration of surgery', 'timeFrame': 'Day 0'}, {'measure': 'morcellation time', 'timeFrame': 'Day 0 - during surgery'}, {'measure': 'peritoneal washing time', 'timeFrame': 'Day 0 - during surgery'}, {'measure': 'residual morcellated tissues weight', 'timeFrame': 'Day 0 - during surgery'}, {'measure': 'bag associated time', 'timeFrame': 'Day 0 - during surgery'}, {'measure': 'ease of use', 'timeFrame': 'Day 0 - during surgery', 'description': 'assessment by a visual analogical scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hysterectomy, Vaginal', 'Uterine Myomatosis', 'Morcellation', 'Laparoscopy', 'in-bag morcellation'], 'conditions': ['Uterine Myomatosis', 'Laparoscopy', 'Hysterectomy, Vaginal']}, 'referencesModule': {'references': [{'pmid': '34136570', 'type': 'BACKGROUND', 'citation': 'Bensouda-Miguet C, Nohuz E, Cerruto E, Buenerd A, Nadaud B, Moret S, Chene G. Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial. Biomed Res Int. 2021 May 26;2021:6611448. doi: 10.1155/2021/6611448. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.\n\nThe hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 years or more\n* Laparoscopic myomectomy or laparoscopic subtotal hysterectomy\n* Informed and signed consent\n\nExclusion Criteria:\n\n* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.\n* Preoperative risk of leiomyosarcoma or pelvic carcinoma\n* Pregnancy or desire of pregnancy during the study period\n* Uterus or myomas weight above 1.000 g\n* Inability to understand information provided\n* Not covered by a national health insurance scheme, prisoner or under administrative supervision'}, 'identificationModule': {'nctId': 'NCT03281460', 'acronym': 'FIBROSAC', 'briefTitle': 'Efficacy of In-bag Morcellation', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Efficacy of In-bag Morcellation', 'orgStudyIdInfo': {'id': '69HCL16_0714'}, 'secondaryIdInfos': [{'id': '2017-A01773-50', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'with in-bag morcellation', 'description': 'with More-cell-Safe AMI bag morcellation', 'interventionNames': ['Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'without any morcellation bag', 'description': 'without any morcellation bag', 'interventionNames': ['Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag']}], 'interventions': [{'name': 'laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation', 'type': 'DEVICE', 'description': 'laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation', 'armGroupLabels': ['with in-bag morcellation']}, {'name': 'laparoscopic myomectomy or hysterectomy without any morcellation bag', 'type': 'PROCEDURE', 'description': 'laparoscopic myomectomy or hysterectomy without any morcellation bag', 'armGroupLabels': ['without any morcellation bag']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Gynaecology Department, Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Gautier CHENE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynaecology Department, Hôpital Femme Mère Enfant, HCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}