Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-01 @ 9:47 AM
Study NCT ID:
NCT01598467
Status:
UNKNOWN
Last Update Posted:
2018-02-22
First Post:
2012-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-15', 'studyFirstSubmitDate': '2012-05-08', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)', 'timeFrame': '6 months', 'description': 'anatomical cure (defined as any simplified POP-Q point \\<2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be ≥2, this will be recorded as a recurrent prolapse.'}], 'secondaryOutcomes': [{'measure': 'intra- peri- and postoperative complications', 'timeFrame': 'intraoperative to 6 weeks after surgery', 'description': 'complications occurring during surgery are defined as "intraoperative complication", within 3 weeks from surgery will be defined as "perioperative complication". Complications occurring after this timeframe will be regarded as "late complications", if related to surgery (e.g. mesh erosion)'}, {'measure': 'quality of life', 'timeFrame': '6 weeks, 6 months, 1 year (yearly thereafter, if feasible)', 'description': 'impact of prolapse repair on quality of life will be assessed via specific validated questionnaires (PFIQ-7, PISQ-12)'}, {'measure': 'postoperative pain', 'timeFrame': 'on postoperative day 1', 'description': 'pain will be assessed on a visual analogue scale (range 0 to 10= 0 no pain, 10 unbearable pain)'}, {'measure': 'intraoperative variables', 'timeFrame': 'intraoperative', 'description': 'intraoperative variables are recorded, such as: blood loss, duration of surgery (divided in robotic setup time, console time and surgery completion time). Concomitant procedures, such as adhesiolysis will also be recorded'}, {'measure': 'impact of uterus management', 'timeFrame': '6 weeks, 6 months, 1 year (yearly thereafter, if feasible)', 'description': 'logistic regression analysis will be performed to evaluate if different surgical approaches in presence, -or absence, of the uterus (e.g. supracervical hysterectomy, uterus sparing surgery), have an effect on primary and secondary outcomes'}, {'measure': 'anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)', 'timeFrame': '6 weeks', 'description': 'anatomical cure (defined as any simplified POP-Q point \\<2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be ≥2, this will be recorded as a recurrent prolapse.'}, {'measure': 'anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)', 'timeFrame': '1 year, yearly thereafter (if feasible)', 'description': 'anatomical cure (defined as any simplified POP-Q point \\<2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be ≥2, this will be recorded as a recurrent prolapse.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pelvic organ prolapse', 'POP', 'sacrocolpopexy', 'sacrohysteropexy', 'promontofixation', 'colpopexy', 'robotic surgery', 'surgical complications', 'mesh', 'prolapse repair'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '30924606', 'type': 'DERIVED', 'citation': "van Zanten F, Schraffordt Koops SE, O'Sullivan OE, Lenters E, Broeders I, O'Reilly BA. Robot-assisted surgery for the management of apical prolapse: a bi-centre prospective cohort study. BJOG. 2019 Jul;126(8):1065-1073. doi: 10.1111/1471-0528.15696. Epub 2019 May 2."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.', 'detailedDescription': 'To prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.\n\nPrimary outcome: anatomical cure rate (using simplified POP-Q staging system)\n\nSecondary outcomes:\n\ncomplication assessment (Clavien-Dindo), functional results, intraoperative variables, impact of surgery on quality of life (PFIQ-7, PISQ-12)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater\n\nExclusion Criteria:\n\n* Poor health status with inability to undergo general anaesthesia\n* Age \\< 18 years\n* ≥ 3 previous laparotomic surgeries\n* Planned pregnancy\n* Other: known pelvic malignancies, previous pelvic radiotherapy, congenital anomalies of genitourinary tract, autoimmune diseases with connective tissue involvement (Lupus, Sjogren Sdr, sclerodermia, etc.), current UTI's, use of steroids, anticoagulants, interstitial cystitis"}, 'identificationModule': {'nctId': 'NCT01598467', 'acronym': 'PARSEC', 'briefTitle': 'Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)', 'organization': {'class': 'OTHER', 'fullName': 'Cork University Hospital'}, 'officialTitle': 'Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)', 'orgStudyIdInfo': {'id': 'PARSEC-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Women with pelvic organ prolapse', 'description': 'Women with pelvic organ prolapse (simplified POP-Q \\> stage 1)', 'interventionNames': ['Procedure: Robotic assisted sacrocolpopexy (RASC)']}], 'interventions': [{'name': 'Robotic assisted sacrocolpopexy (RASC)', 'type': 'PROCEDURE', 'otherNames': ['sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexy'], 'description': 'Robotic assisted sacrocolpopexy (RASC) will be performed with the Da Vinci Surgical robot (Intuitive Surgical). THe mesh used will be a Type I (Amid classification), polypropylene mesh', 'armGroupLabels': ['Women with pelvic organ prolapse']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Lorenzo Dutto, MD', 'role': 'CONTACT', 'email': 'lorenzo.dutto@fastwebnet.it', 'phone': '00353(83)3247511'}, {'name': "Barry O'Reilly", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cork University Maternity Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}], 'centralContacts': [{'name': 'Lorenzo Dutto, MD', 'role': 'CONTACT', 'email': 'lorenzo.dutto@fastwebnet.it', 'phone': '00353-833247511'}], 'overallOfficials': [{'name': "Barry O'Reilly", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cork University Hospital'}, {'name': 'Steven E Schraffordt Koops', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The Netherlands'}, {'name': 'Lorenzo Dutto', 'role': 'STUDY_CHAIR', 'affiliation': 'Cork University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Femke van Zanten', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Study Coordinator, urologist, urogynaecology fellow', 'investigatorFullName': 'Femke van Zanten', 'investigatorAffiliation': 'Cork University Hospital'}}}}