Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT05421156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-11-02
First Post:
2022-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-06-12', 'studyFirstSubmitQcDate': '2022-06-12', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual Dysfunctions', 'timeFrame': '5 years after surgery', 'description': 'Female Sexual Function Index'}], 'secondaryOutcomes': [{'measure': 'Urinary Dysfunctions', 'timeFrame': '5 years after surgery', 'description': 'Pelvic Floor Distress Inventory short form'}, {'measure': 'Pelvic Organ Prolapse', 'timeFrame': '5 years after surgery', 'description': 'Pelvic Organ Prolapse (POP-Q) evaluation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subtotal Laparoscopic Hysterectomy', 'Total Laparoscopic Hysterectomy', 'Hysterectomy'], 'conditions': ['Hysterectomy']}, 'descriptionModule': {'briefSummary': 'Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions.\n\nExclusion Criteria:\n\n* Women with gynecological and non-gynecological cancers.'}, 'identificationModule': {'nctId': 'NCT05421156', 'acronym': 'LAST-1', 'briefTitle': 'Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Evaluation of Long-term Sexual Dysfunctions, Urinary Dysfunctions and Pelvic Organ Prolapse in Women Who Underwent Laparoscopic Subtotal Versus Total Hysterectomy for Benign Conditions', 'orgStudyIdInfo': {'id': 'LAST-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subtotal Laparoscopic Hysterectomy', 'description': 'Women who underwent subtotal laparoscopic hysterectomy', 'interventionNames': ['Procedure: Subtotal Laparoscopic Hysterectomy']}, {'label': 'Total Laparoscopic Hysterectomy', 'description': 'Women who underwent total laparoscopic hysterectomy', 'interventionNames': ['Procedure: Total Laparoscopic Hysterectomy']}], 'interventions': [{'name': 'Subtotal Laparoscopic Hysterectomy', 'type': 'PROCEDURE', 'description': 'Subtotal laparoscopic hysterectomy involves removing the main body of the uterus and leaving the cervix in place by laparoscopy.', 'armGroupLabels': ['Subtotal Laparoscopic Hysterectomy']}, {'name': 'Total Laparoscopic Hysterectomy', 'type': 'PROCEDURE', 'description': 'Total laparoscopic hysterectomy involves removing the whole uterus and cervix by laparoscopy', 'armGroupLabels': ['Total Laparoscopic Hysterectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Antonio Simone Laganà, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'antoniosimone.lagana@unipa.it', 'phone': '3296279579'}], 'overallOfficials': [{'name': 'Antonio Simone Laganà, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Palermo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Simone Laganà', 'investigatorAffiliation': 'University of Palermo'}}}}