Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:49 PM
Study NCT ID:
NCT03410303
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2017-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Per-operative Ultrasonographic Assessement of the Placement of the Mesh in Laparoscopic Sacral Colpo/Hysteropexy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.', 'timeFrame': 'at two months (± 1 month) of follow-up', 'description': 'Comparaison of intraoperative measurement to postoperative measurement'}], 'secondaryOutcomes': [{'measure': 'Stage of prolapse', 'timeFrame': 'until 2 months post-operative', 'description': 'Evaluate the stage of prolapse on clinical examination according to the International Continence Society (ICS) of Pelvic Organ Prolapse Quantification System (POP-Q) classification (points Ba, Bp, C, D)'}, {'measure': 'Evaluate the symptoms with the PFDI-20 questionnaire', 'timeFrame': 'during 2 months post-operative', 'description': 'The Pelvic Floor Disorders Inventory (PFDI-20) score : This is a questionnaire so that patients can answer questions about certain symptoms: intestines, bladder or pelvic'}, {'measure': 'Evaluate patient satisfaction with the PGI-I questionnaire (1-7)', 'timeFrame': 'until 2 months post-operative', 'description': 'The Patient Global Impression of Improvement (PGI-I) : The patient should check the box corresponding to the current state of her uro-gynecological problems compared to what they were before treatment'}, {'measure': 'Evaluate the symptoms with the PFIQ-7 questionnaire', 'timeFrame': 'during 2 months post-operative', 'description': 'The Pelvic Floor Impact Questionnaire (PFIQ-7) : describe how much les activities, relationships, or feelings have been affected by symptoms bladder, bowel, or vaginal or conditions over.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['LAPAROSCOPY', 'Sacrum; Anomaly']}, 'descriptionModule': {'briefSummary': 'This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.', 'detailedDescription': 'Genital prolapse is a very common functional pathology that affects 30% of women. The functional impact of prolapse is highly variable and may lead patients to consider surgery. Surgery for laparoscopic genital prolapse (laparoscopy) is a common practice. The placement of prostheses on the anterior and posterior walls of the vagina is sort of "estimated", performed without any quality control . This technique is associated with a high rate of patient satisfaction (90% satisfaction), but a risk of anatomical recurrence in 20-30% of cases and a risk of reoperation for relapse in 3% of cases. It is likely that the lower the intervesico-vaginal prosthesis, the lower the risk of cystocele relapse is important.The postoperative ultrasound visualization of prostheses placed in promontofixation is possible: they appear hyperechoic. In particular, in anterior, where a prosthesis is placed between the vagina and the bladder, it is possible to verify that this prosthesis supports the entire bladder base.Thus, it may be possible to check the correct position of the prostheses intraoperatively. If studies were conducted postoperatively, to the best of our knowledge, no study has been conducted on the value of an intraoperative ultrasound control.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women (\\>18 years-old)\n* patient who undergo laparoscopic sacral copopexy/hysteropexy\n* Affiliation to a public health insurance system\n* Written and informed consent given by the patient\n\nExclusion Criteria:\n\n* Pregnancy, breast-feading\n* woan involved in an interventional research\n* Patient under tutorship or curatorship\n* Pregnancy and breast feeding'}, 'identificationModule': {'nctId': 'NCT03410303', 'acronym': 'SONOMESH', 'briefTitle': 'Per-operative Ultrasonographic Assessement of the Placement of the Mesh in Laparoscopic Sacral Colpo/Hysteropexy', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of Intraoperative Ultrasound for the Positioning of Prostheses in Laparoscopic Surgery of Genital Prolapse', 'orgStudyIdInfo': {'id': 'K160801J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intraoperative ultrasound', 'description': 'An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.', 'interventionNames': ['Diagnostic Test: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)']}], 'interventions': [{'name': 'Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)', 'type': 'DIAGNOSTIC_TEST', 'description': 'An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.', 'armGroupLabels': ['Intraoperative ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clamart', 'country': 'France', 'facility': 'Xavier DEFFIEUX', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}], 'overallOfficials': [{'name': 'Xavier DEFFIEUX', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP, Antoine Béclère Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}