Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 1:55 PM
Study NCT ID:
NCT05276804
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The POUR (Postoperative Urinary Retention) Study
Sponsor:
Organization:
Raw JSON
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Scarola', 'organization': 'Atrium Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 2', 'description': 'Number of adverse events reported', 'eventGroups': [{'id': 'EG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Urinary Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'OG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 hours postop', 'description': 'Urinary retention is defined as the inability to void at six hours postoperatively, which will be recorded in the postoperative recovery area and the same definition for urinary retention will be applied to the comparative retrospective cohort', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'OG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From post op to discharge (up to 365 days)', 'description': 'Patients will be followed from post surgery until discharge to determine the interim time', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'OG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'classes': [{'categories': [{'measurements': [{'value': '57954', 'spread': '13448', 'groupId': 'OG000'}, {'value': '54970', 'spread': '19324', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (up to 365 days)', 'description': 'Patient costs associated with procedure and hospital stay', 'unitOfMeasure': 'USD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'OG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'timeFrame': 'Week 2', 'description': 'Quality of life survey given post hernia repair to evaluate mesh sensation, pain and movement limitations. 23 total items. Each item is scored 0 (no symptoms) to 5 (disabling symptoms). Total score range is 0-115 with a low score indicating surgery had no negative impact on quality of life.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure type was entered incorrectly when the study was initially registered. The QOL survey should have been designated as "other."'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Operation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'OG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'classes': [{'categories': [{'measurements': [{'value': '105.9', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '102.1', 'spread': '51.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Number of minutes the operation lasted', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Morphine Milligram Equivalents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. 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Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'OG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '38.0', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Morphine milligram equivalents (MME) represents the potency of an opioid dose relative to morphine. 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Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'OG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 2', 'description': 'Number of participants with clean wounds based on the Center for Disease Control and Prevention (CDC) Wound guidelines. CDC wound classification options are Clean, Clean-Contaminated, Contaminated, and Dirty/Infected.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. 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Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'FG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '74 prospectively enrolled into Sugammadex group 74 retrospectively matched from baseline (non-Sugammadex) group'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.'}, {'id': 'BG001', 'title': 'Retrospective Cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age at time of surgery, in years', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Count and percentage of males and females', 'calculatePct': False, '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': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '121', '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': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race of participants', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'History of BPH (Benign prostatic hyperplasia)', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Count of BPH history', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Side of Inguinal Repair', 'classes': [{'categories': [{'title': 'Unilateral', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Bilateral', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Bilateral vs Unilateral Repair', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Surgical Repair Technique', 'classes': [{'categories': [{'title': 'Laparoscopic', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Robotic', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Planned operative technique for inguinal hernia repair', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Tobacco Status', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Former', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Current', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Tobacco status of the participant at time baseline', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Primary vs Recurrent Repair', 'classes': [{'categories': [{'title': 'Primary', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Recurrent', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Primary or recurrent hernia repair', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Status', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Diabetes Status at time of surgery', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Steroids Use', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Steroids use at time of surgery', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-20', 'size': 277677, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-27T13:41', 'hasProtocol': True}, {'date': '2023-11-20', 'size': 177518, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-30T10:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2022-03-01', 'resultsFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-18', 'studyFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life Survey', 'timeFrame': 'Week 2', 'description': 'Quality of life survey given post hernia repair to evaluate mesh sensation, pain and movement limitations. 23 total items. Each item is scored 0 (no symptoms) to 5 (disabling symptoms). Total score range is 0-115 with a low score indicating surgery had no negative impact on quality of life.'}, {'measure': 'Operation Time', 'timeFrame': 'Day 1', 'description': 'Number of minutes the operation lasted'}, {'measure': 'Morphine Milligram Equivalents', 'timeFrame': 'Day 1', 'description': 'Morphine milligram equivalents (MME) represents the potency of an opioid dose relative to morphine. MME is intended to help clinicians make safe, appropriate decisions concerning changes to opioid regimens.'}, {'measure': 'Number of Participants With Clean Wounds at Follow Up', 'timeFrame': 'Up to Week 2', 'description': 'Number of participants with clean wounds based on the Center for Disease Control and Prevention (CDC) Wound guidelines. CDC wound classification options are Clean, Clean-Contaminated, Contaminated, and Dirty/Infected.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Urinary Retention', 'timeFrame': '6 hours postop', 'description': 'Urinary retention is defined as the inability to void at six hours postoperatively, which will be recorded in the postoperative recovery area and the same definition for urinary retention will be applied to the comparative retrospective cohort'}], 'secondaryOutcomes': [{'measure': 'Length of Stay (Days)', 'timeFrame': 'From post op to discharge (up to 365 days)', 'description': 'Patients will be followed from post surgery until discharge to determine the interim time'}, {'measure': 'Hospital Cost', 'timeFrame': 'At discharge (up to 365 days)', 'description': 'Patient costs associated with procedure and hospital stay'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sugammadex'], 'conditions': ['Postoperative Urinary Retention']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents', 'detailedDescription': 'Postoperative urinary retention following laparoscopic inguinal hernia repair occurs in approximately one out of ten patients. The more rapid reversal of neuromuscular blockade with Sugammadex has empirically been associated with low rates of postoperative urinary retention. In this study, patients will receive Sugammadex following laparoscopic inguinal hernia repair and then be retrospectively matched against a group of patients who did not receive Sugammadex. The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents (e.g. neostigmine which has a retention rate of 5-11%). We will also examine difference in cost and quality of life between the two groups. Our hypothesis is that the use of Sugammadex will decrease rate of postoperative urinary retention, decrease associated cost, such as need for admission, and not negatively impact quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over the age of 18\n* Undergoing laparoscopic inguinal hernia repair at Carolinas Medical Center by attending surgeons within the Division of Gastrointestinal and Minimally Invasive Surgery\n* Unilateral or bilateral inguinal hernia repair; may have concurrent umbilical hernia repair performed\n* Agreeable to participation in the study\n\nExclusion Criteria:\n\n* Patients who are having concurrent ventral or flank hernias repaired at time of operation or are having an inguinal hernia repair along with another operation (e.g.\n\nlaparoscopic cholecystectomy)\n\n* End-stage renal disease (Creatinine clearance less than 30)\n* Neuromuscular disease\n* Prior adverse reactions to Sugammadex\n* Patients who do not provide consent for the study'}, 'identificationModule': {'nctId': 'NCT05276804', 'acronym': 'POUR', 'briefTitle': 'The POUR (Postoperative Urinary Retention) Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary Retention (POUR) Following Laparoscopic Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'IRB00083113'}, 'secondaryIdInfos': [{'id': '01-22-45E', 'type': 'OTHER', 'domain': 'Atrium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex', 'description': 'Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.', 'interventionNames': ['Drug: Sugammadex']}, {'type': 'NO_INTERVENTION', 'label': 'Retrospective cohort', 'description': 'Retrospective cohort of patients who did not receive Sugammadex'}], 'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'description': 'The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.', 'armGroupLabels': ['Sugammadex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Brant T Heniford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}