Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-30 @ 8:10 AM
Study NCT ID:
NCT01044212
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2010-01-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bowel Function After Minimally Invasive Urogynecologic Surgery
Sponsor:
Organization:
Raw JSON
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2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Docusate Controls', 'description': 'Docusate is the standard of care regimen\n\nDocusate sodium : Docusate 100mg BID', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Post-op Bowel Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bowel Medications', 'description': 'Docusate, Miralax, Metamucil wafers, Bisacodyl suppository\n\nBowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID'}, {'id': 'OG001', 'title': 'Docusate Controls', 'description': 'Docusate is the standard of care regimen\n\nDocusate sodium : Docusate 100mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '21', 'groupId': 'OG000'}, {'value': '77', 'spread': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 1 week of surgery', 'description': 'The time to first post-operative bowel movement was measured in hours after surgery.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Power analysis'}, {'type': 'SECONDARY', 'title': 'Pain Level Associated With First Postoperative Bowel Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bowel Medications', 'description': 'Docusate, Miralax, Metamucil wafers, Bisacodyl suppository\n\nBowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID'}, {'id': 'OG001', 'title': 'Docusate Controls', 'description': 'Docusate is the standard of care regimen\n\nDocusate sodium : Docusate 100mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 1 week of surgery', 'description': 'The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.', 'unitOfMeasure': 'VAS pain score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Consistency of First Postoperative Bowel Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bowel Medications', 'description': 'Docusate, Miralax, Metamucil wafers, Bisacodyl suppository\n\nBowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID'}, {'id': 'OG001', 'title': 'Docusate Controls', 'description': 'Docusate is the standard of care regimen\n\nDocusate sodium : Docusate 100mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '3.13', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 1 week of surgery', 'description': 'The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol\\_stool\\_scale.\n\nThe seven types of stool are:\n\nType 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid', 'unitOfMeasure': 'Bristol Stool Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bowel Medications', 'description': 'Docusate, Miralax, Metamucil wafers, Bisacodyl suppository\n\nBowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID'}, {'id': 'FG001', 'title': 'Docusate Controls', 'description': 'Docusate is the standard of care regimen\n\nDocusate sodium : Docusate 100mg BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Candidates meeting criteria were offered participation at their preoperative visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bowel Medications', 'description': 'Docusate, Miralax, Metamucil wafers, Bisacodyl suppository\n\nBowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID'}, {'id': 'BG001', 'title': 'Docusate Controls', 'description': 'Docusate is the standard of care regimen\n\nDocusate sodium : Docusate 100mg BID'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '10', 'groupId': 'BG000'}, {'value': '63', 'spread': '9', 'groupId': 'BG001'}, {'value': '61', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2010-01-05', 'resultsFirstSubmitDate': '2012-09-14', 'studyFirstSubmitQcDate': '2010-01-06', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-21', 'studyFirstPostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Post-op Bowel Movement', 'timeFrame': 'Within 1 week of surgery', 'description': 'The time to first post-operative bowel movement was measured in hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Pain Level Associated With First Postoperative Bowel Movement', 'timeFrame': 'Within 1 week of surgery', 'description': 'The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.'}, {'measure': 'Consistency of First Postoperative Bowel Movement', 'timeFrame': 'Within 1 week of surgery', 'description': 'The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol\\_stool\\_scale.\n\nThe seven types of stool are:\n\nType 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urogynecology'], 'conditions': ['Functional Disorder of Intestine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.', 'detailedDescription': 'See above'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.\n\nProcedures may include:\n\n* robot-assisted laparoscopic sacrocolpopexy\n* sacrospinous ligament suspension\n* uterosacral ligament suspension/paravaginal defect repair\n* colpocleisis\n* cystocele repair\n\nAdditional procedures may include:\n\n* hysterectomy\n* adnexectomy\n* culdoplasty\n* minimally invasive sling procedure (TVT or TOT)\n* periurethral collagen injections\n* enterocele repair\n\nExclusion Criteria:\n\n* Planning to undergo laparotomy.\n* Undergoing rectocele or perineocele repair as part of surgery.\n* Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.\n* Presence of a colostomy.\n* Chronic kidney disease\n* Insulin-dependent diabetes mellitus\n* Known cardiac disease\n* Gastric ulcers\n* Difficulty swallowing or esophageal stricture\n* Persistent nausea and vomiting\n* Signs and symptoms consistent with bowel obstruction'}, 'identificationModule': {'nctId': 'NCT01044212', 'briefTitle': 'Bowel Function After Minimally Invasive Urogynecologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '29359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Docusate', 'description': 'Docusate is the standard of care regimen', 'interventionNames': ['Drug: Docusate']}, {'type': 'EXPERIMENTAL', 'label': 'Bowel medications', 'description': 'Docusate, Miralax, Metamucil wafers, Bisacodyl suppository', 'interventionNames': ['Drug: Bowel medications']}], 'interventions': [{'name': 'Docusate', 'type': 'DRUG', 'otherNames': ['Colace'], 'description': 'Docusate 100mg BID', 'armGroupLabels': ['Docusate']}, {'name': 'Bowel medications', 'type': 'DRUG', 'otherNames': ['Colace', 'Psyllium', 'Polyethylene glycol', 'Dulcolax'], 'description': 'Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID', 'armGroupLabels': ['Bowel medications']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Gunhilde Buchsbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gunhilde Buchsbaum', 'investigatorAffiliation': 'University of Rochester'}}}}