Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-28 @ 12:37 PM
Study NCT ID:
NCT01618292
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2012-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 393}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-27', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in bowel function', 'timeFrame': 'preoperatively, 6 months, and one year post-surgery', 'description': '-Patients completed a validated colo-rectal-anal distress inventory (CARDI-8) at all 3 intervals. Specific complaints of splinting with defecation, excessive straining/pain with bowel movements, incomplete bowel emptying/obstructive symptoms and fecal incontinence were addressed. In addition, patients completed a validated colorectal-anal impact questionnaire (CRAIQ-7) at all 3 intervals. The CRAIQ-7 addresses bowel symptoms and the extend of quality of life impingement'}], 'secondaryOutcomes': [{'measure': 'Objective anatomic outcomes', 'timeFrame': 'preoperatively, 6 months, and one year after surgery', 'description': 'The pelvic organ prolapse quantification system (POP-Q)- an objective, validated, standardized method of quantifying the degree of pelvic organ prolapse present was used at all visits.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pelvic organ prolapse', 'constipation', 'bowel dysfunction', 'irritable bowel syndrome (IBS)', 'CRADI-8', 'CRAIQ-7', 'splinting with defecation', 'excessive straining', 'bowel movements', 'fecal incontinence', 'bowel symptoms'], 'conditions': ['Pelvic Organ Prolapse', 'Constipation', 'Bowel Dysfunction', 'Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Compare changes in bowel function before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women suffering from pelvic organ prolapse who underwent a robotic assisted laparoscopic sacral colpopexy between January 2007 and August 2011.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who underwent robotic assisted laparoscopic sacral colpopexy\n\nExclusion Criteria:\n\n* Any other procedure for the treatment of pelvic organ prolapse'}, 'identificationModule': {'nctId': 'NCT01618292', 'briefTitle': 'Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': 'Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy', 'orgStudyIdInfo': {'id': 'R11-08-011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robotic-assisted sacrocolpopexy patients', 'description': 'Patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 and August 2011.', 'interventionNames': ['Procedure: Robotic sacral colpopexy']}], 'interventions': [{'name': 'Robotic sacral colpopexy', 'type': 'PROCEDURE', 'otherNames': ['robotic-assisted laparoscopic sacral colpopexy'], 'description': 'Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse', 'armGroupLabels': ['Robotic-assisted sacrocolpopexy patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health System', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}], 'overallOfficials': [{'name': 'Patrick Culligan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlantic Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Patrick Culligan, MD', 'investigatorFullName': 'Jennifer Pagnillo', 'investigatorAffiliation': 'Atlantic Health System'}}}}