Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-27 @ 7:30 AM
Study NCT ID:
NCT03684304
Status:
TERMINATED
Last Update Posted:
2022-05-11
First Post:
2018-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@uhhospitals.org', 'phone': '216-844-1000', 'title': 'University Hospitals', 'organization': 'University Hospitals'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Death, serious adverse events, and other were not assessed for this study', 'eventGroups': [{'id': 'EG000', 'title': 'Control / No Binder', 'description': 'Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Abdominal Binder', 'description': 'Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.\n\nAbdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control / No Binder', 'description': 'Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.'}, {'id': 'OG001', 'title': 'Abdominal Binder', 'description': 'Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.\n\nAbdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.'}], 'timeFrame': '7 days', 'description': 'Total narcotic usage, calculated in morphine equivalents, during the first seven days post operatively to be calculated and a difference in the amount used by non-abdominal binder patients and abdominal binder patients will be determined. Will review medical record to determine amount of medication used while inpatient, amount / type of narcotic medication prescribed for discharge home, and will call patients to determine how many narcotic pills they have remaining on post operative day seven and calculate the amount used which will then be converted to morphine equivalents.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'SECONDARY', 'title': 'To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control / No Binder', 'description': 'Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.'}, {'id': 'OG001', 'title': 'Abdominal Binder', 'description': 'Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.\n\nAbdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.'}], 'timeFrame': '1 day', 'description': 'Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'SECONDARY', 'title': 'To Compare Post Operative Pain Scores Using Visual Analog Scale (VAS) Scores in Post Operatives Patients Who Use and do Not Use an Abdominal Binder.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control / No Binder', 'description': 'Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.'}, {'id': 'OG001', 'title': 'Abdominal Binder', 'description': 'Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.\n\nAbdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.'}], 'timeFrame': '1 day', 'description': 'Difference in VAS pain scores will be obtained only while the patient is admitted to the hospital post operatively between non-abdominal binder patients and abdominal binder patients.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control / No Binder', 'description': 'Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.'}, {'id': 'FG001', 'title': 'Abdominal Binder', 'description': 'Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.\n\nAbdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control / No Binder', 'description': 'Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.'}, {'id': 'BG001', 'title': 'Abdominal Binder', 'description': 'Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.\n\nAbdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '51'}, {'value': '51', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '51'}, {'value': '51', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '51'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-24', 'size': 304502, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-13T14:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Patients no longer staying overnight in the hospital following this procedure type.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2018-04-24', 'resultsFirstSubmitDate': '2022-03-06', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-13', 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery', 'timeFrame': '7 days', 'description': 'Total narcotic usage, calculated in morphine equivalents, during the first seven days post operatively to be calculated and a difference in the amount used by non-abdominal binder patients and abdominal binder patients will be determined. Will review medical record to determine amount of medication used while inpatient, amount / type of narcotic medication prescribed for discharge home, and will call patients to determine how many narcotic pills they have remaining on post operative day seven and calculate the amount used which will then be converted to morphine equivalents.'}], 'secondaryOutcomes': [{'measure': 'To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.', 'timeFrame': '1 day', 'description': 'Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients.'}, {'measure': 'To Compare Post Operative Pain Scores Using Visual Analog Scale (VAS) Scores in Post Operatives Patients Who Use and do Not Use an Abdominal Binder.', 'timeFrame': '1 day', 'description': 'Difference in VAS pain scores will be obtained only while the patient is admitted to the hospital post operatively between non-abdominal binder patients and abdominal binder patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pelvic Organ Prolapse', 'Abdominal Surgery', 'Laparoscopic Surgery', 'Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'To determine the effect of post-operative abdominal binder usage on total narcotic usage after undergoing surgery. To determine if abdominal binder usage results in decreased visual analog scale (VAS) pain scores and shorter time to first ambulation post operatively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Based on female biological sex due to requirement of pelvic surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 18 years or older.\n* Willing and able to provide informed consent.\n* Patients must be undergoing scheduled pelvic surgery.\n* Patients must be admitted overnight (at least one night) after surgery.\n\nExclusion Criteria:\n\n* Patients who are younger than 18 years old.\n* Patients who are unable or unwilling to provide informed consent.\n* Patients who are illiterate.\n* Patients who are non-English speaking or reading.\n* Patients who are unwilling to be contacted by phone after surgery.\n* Patients who are undergoing pelvic surgery that does not warrant observation or admission after surgery for at least one night.\n* Patients who are having surgery for any other indication other than pelvic surgery.\n* Patients with a chronic pain syndrome (as evidenced by daily intake of opioids).'}, 'identificationModule': {'nctId': 'NCT03684304', 'briefTitle': 'The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'binder071718'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control / No Binder', 'description': 'Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.'}, {'type': 'EXPERIMENTAL', 'label': 'Abdominal binder', 'description': 'Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.', 'interventionNames': ['Device: Abdominal binder']}], 'interventions': [{'name': 'Abdominal binder', 'type': 'DEVICE', 'description': 'The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.', 'armGroupLabels': ['Abdominal binder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician, Primary Investigator', 'investigatorFullName': 'Caitlin Carlton', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}