Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT02248935
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2014-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure Rate', 'timeFrame': '5-6 years', 'description': 'To be considered a "clinical cure" subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of "satisfied" or "very satisfied" on validated Surgical Satisfaction Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Objective Anatomic Outcome', 'timeFrame': '5-6 year', 'description': 'POP-Q measurements of Pelvic Organ Prolapse will be measured comparing both mesh groups and entire combined cohort compared to 12 month findings'}, {'measure': 'Mesh exposure/erosion', 'timeFrame': '5-6 years', 'description': 'The rate of mesh exposure or erosion will be measured'}, {'measure': 'Complications', 'timeFrame': '5-6 years', 'description': 'any other complications related to the index surgery will be documented'}, {'measure': 'Symptom Comparison', 'timeFrame': '5-6 years', 'description': 'to compare related symptoms such as urinary frequency, bowel function, and sexual function both between mesh groups and for the entire group compared to 12 month findings'}, {'measure': 'Surgical Satisfaction', 'timeFrame': '5-6 years', 'description': 'The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Robotic Assisted Laparoscopic Sacrocolpopexy', 'Y Mesh', 'Pelvic Organ Prolapse'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '31688526', 'type': 'DERIVED', 'citation': 'Culligan PJ, Lewis C, Priestley J, Mushonga N. Long-Term Outcomes of Robotic-Assisted Laparoscopic Sacrocolpopexy Using Lightweight Y-Mesh. Female Pelvic Med Reconstr Surg. 2020 Mar;26(3):202-206. doi: 10.1097/SPV.0000000000000788.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who had a robotic-assisted laparoscopic sacrocolpopexy using either mentioned Y-mesh during the listed timeframe. All of the index cases were performed by fellowship-trained FPMRS specialists.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh\n\nExclusion Criteria:\n\n* Refusal to participate in our long-term outcome study'}, 'identificationModule': {'nctId': 'NCT02248935', 'briefTitle': 'Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': 'Prospective Cohort Study Comparing Two Lightweight Y Meshes After Robotic-Assisted Laparoscopic Sacrocolpopexy Longterm Outcomes', 'orgStudyIdInfo': {'id': '599819-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Repair with Alyte or Restorelle Y-Mesh', 'description': 'Women who underwent their index robotic-assisted laparoscopic sacrocolpopexy at Morristown Medical Center or Overlook Medical Center using either the Alyte Y-mesh or Restorelle Y-smartmesh between 1/2007 and 8/2011.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Department of Urogynecology-Atlantic Health System', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}