Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT02667002
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-13', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomic Success', 'timeFrame': 'One month', 'description': 'anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '22890409', 'type': 'RESULT', 'citation': 'Jager W, Mirenska O, Brugge S. Surgical treatment of mixed and urge urinary incontinence in women. Gynecol Obstet Invest. 2012;74(2):157-64. doi: 10.1159/000339972. Epub 2012 Aug 9.'}, {'pmid': '11795640', 'type': 'RESULT', 'citation': 'Sze EH, Meranus J, Kohli N, Miklos JR, Karram MM. Vaginal configuration on MRI after abdominal sacrocolpopexy and sacrospinous ligament suspension. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):375-9; discussion 379-80. doi: 10.1007/s001920170016.'}, {'pmid': '25961042', 'type': 'RESULT', 'citation': 'Joukhadar R, Meyberg-Solomayer G, Hamza A, Radosa J, Bader W, Barski D, Ismaeel F, Schneider G, Solomayer E, Baum S. A Novel Operative Procedure for Pelvic Organ Prolapse Utilizing a MRI-Visible Mesh Implant: Safety and Outcome of Modified Laparoscopic Bilateral Sacropexy. Biomed Res Int. 2015;2015:860784. doi: 10.1155/2015/860784. Epub 2015 Apr 19.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22890409', 'label': 'pubmed'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25961042', 'label': 'pubmed'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=Vaginal+Configuration+on+MRI+after+Abdominal+Sacrocolpopexy+and+Sacrospinous+Ligament+Suspension', 'label': 'pubmed'}]}, 'descriptionModule': {'briefSummary': 'Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.', 'detailedDescription': 'Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with stage 3 or more pelvic organ prolapse\n\nExclusion Criteria:\n\n* Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy'}, 'identificationModule': {'nctId': 'NCT02667002', 'briefTitle': 'Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy', 'organization': {'class': 'OTHER', 'fullName': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}, 'officialTitle': 'Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy', 'orgStudyIdInfo': {'id': '162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilateral Abdominal Sacral Hysteropexy', 'description': 'Bilateral abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.', 'interventionNames': ['Procedure: Bilateral Abdominal Sacral Hysteropexy']}, {'type': 'EXPERIMENTAL', 'label': 'Classic Abdominal Sacral Hysteropexy', 'description': 'Conventional abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.', 'interventionNames': ['Procedure: Conventional abdominal Sacral Hysteropexy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Women with no uterovaginal prolapsed', 'description': 'Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.', 'interventionNames': ['Other: Nulliparous women with no uterovaginal prolapsed']}], 'interventions': [{'name': 'Bilateral Abdominal Sacral Hysteropexy', 'type': 'PROCEDURE', 'description': 'The mesh will be fixed right and left side of sacrum.', 'armGroupLabels': ['Bilateral Abdominal Sacral Hysteropexy']}, {'name': 'Conventional abdominal Sacral Hysteropexy', 'type': 'PROCEDURE', 'description': 'The mesh will be fixed only right side of sacrum', 'armGroupLabels': ['Classic Abdominal Sacral Hysteropexy']}, {'name': 'Nulliparous women with no uterovaginal prolapsed', 'type': 'OTHER', 'description': 'This will be control group which consistent patients with no uterovaginal prolapse.', 'armGroupLabels': ['Women with no uterovaginal prolapsed']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mehmet Baki Şentürk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be available within 1 week of study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehmet Baki Senturk', 'investigatorAffiliation': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}}}}