Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT03838302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-04-29
First Post:
2019-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2019-02-09', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Female Sexual Function Index', 'timeFrame': 'Change from baseline (before surgery) and 2 months after surgery', 'description': 'The Female Sexual Function Index (FSFI) is a brief questionnaire measure of sexual functioning in women.\n\nScore range: minimum 2.0, maximum 36.0. Higher values represent a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual functioning', 'Laparoscopy', 'Colpotomy', 'Specimen retrieval', 'Transvaginal extraction'], 'conditions': ['Transvaginal Tissue Extraction']}, 'descriptionModule': {'briefSummary': "The retrieval of tissues removed by laparoscopic surgery larger than trocars caliber, with preservation of the uterus, required for a long time intraperitoneal electromechanical morcellation, until the Food and Drug Administration expressed concern about intraperitoneal dissemination of malignant cells, in the case of unrecognized sarcomas.\n\nTransvaginal contained tissue extraction via a posterior colpotomy and manual morcellation in the bag is one of the possible alternatives.\n\nAvailable data suggested the effectiveness and safety of this technique, also in terms of time and costs, without a increased risk intra and post-operative complications.\n\nThe available evidence shows the lack of sequelae also on fertility and sexual function.\n\nNevertheless, sexual function has never been evaluated qualitatively in all its aspects nor quantitatively with a validated measurement scale, which can allow us to inform the consequences on the real risk of implications on sexual function determined by vaginal incision. In view of these elements, the aim of the investigator's study is to compare patients in whom laparoscopic tissue removal has been carried out with posterior colpotomy or without it with removal from the trocars."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergoing laparoscopic management for myomas or adnexal disease and with specimen retrieval by transvaginal extraction or transbdominal extraction through trocar.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Benign uterine and adnexal pathology\n* Preservation of the uterus\n* Sexually active women\n* Premenopausal women\n\nExclusion Criteria:\n\n* Pelvic inflammatory disease, endometriosis and pre-existing dyspareunia or chronic pelvic pain of any origin\n* Previous Hysterectomy\n* Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases, psychopathology, mental and sensory-motor disabilities) comorbidities\n* Language barrier'}, 'identificationModule': {'nctId': 'NCT03838302', 'acronym': 'FSF-TVE', 'briefTitle': 'Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Evaluation of Female Sexual Functions With Validated Measurement Scale (Female Sexual Function Index) After Transvaginal Versus Trocars Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation', 'orgStudyIdInfo': {'id': 'FSF-TVE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transvaginal retrieval', 'description': 'Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation', 'interventionNames': ['Procedure: Transvaginal tissue retrieval via a posterior colpotomy']}, {'label': 'Transabdominal retrieval', 'description': 'Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation', 'interventionNames': ['Procedure: Transabdominal retrieval via trocar']}], 'interventions': [{'name': 'Transvaginal tissue retrieval via a posterior colpotomy', 'type': 'PROCEDURE', 'description': 'Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation', 'armGroupLabels': ['Transvaginal retrieval']}, {'name': 'Transabdominal retrieval via trocar', 'type': 'PROCEDURE', 'description': 'Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation', 'armGroupLabels': ['Transabdominal retrieval']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'contacts': [{'name': 'Antonio Simone Laganà, M.D.', 'role': 'CONTACT', 'email': 'antoniosimone.lagana@asst-settelaghi.it', 'phone': '+393296279579'}, {'name': 'Fabio Ghezzi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jvan Casarin, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Simone Garzon, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '"Filippo Del Ponte" Hospital', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'Antonio Simone Laganà, M.D.', 'role': 'CONTACT', 'email': 'antoniosimone.lagana@asst-settelaghi.it', 'phone': '+393296279579'}], 'overallOfficials': [{'name': 'Antonio Simone Laganà, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Simone Laganà', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}