Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-03 @ 5:54 PM
Study NCT ID:
NCT03630393
Status:
TERMINATED
Last Update Posted:
2022-02-18
First Post:
2018-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultralow Versus Standard Pneumoperitoneum Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ryan.hedgepeth@ohiohealth.com', 'phone': '614-788-2870', 'title': 'Dr. Ryan Hedgepeth', 'organization': 'OhioHealth'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Events were tracked through 90 days following discharge via review of medical records', 'eventGroups': [{'id': 'EG000', 'title': 'Pressure 6 mmHg', 'description': 'Pneumoperitoneum Pressure 6 mmHg\n\nPneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Pressure 15 mmHg', 'description': 'Pneumoperitoneum Pressure 15 mmHg\n\nPneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Epigastric bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Pain Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pressure 6 mmHg', 'description': 'Pneumoperitoneum Pressure 6 mmHg\n\nPneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.'}, {'id': 'OG001', 'title': 'Pressure 15 mmHg', 'description': 'Pneumoperitoneum Pressure 15 mmHg\n\nPneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '40.72', 'groupId': 'OG000'}, {'value': '61.2', 'spread': '37.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 1 week postoperatively', 'description': 'The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.', 'unitOfMeasure': 'morphine milligram equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post Operative Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pressure 6 mmHg', 'description': 'Pneumoperitoneum Pressure 6 mmHg\n\nPneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.'}, {'id': 'OG001', 'title': 'Pressure 15 mmHg', 'description': 'Pneumoperitoneum Pressure 15 mmHg\n\nPneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through discharge (post-operative day 0 or post-operative day 1)', 'description': 'Each participant was asked to rate their pain on a 0-10 scale, with higher numbers representing worse pain. Patients rated their pain at the following time points: in the post-anesthesia care unit (PACU) upon waking from anesthesia, at hours 4, 12, 16, and 20 after transfer to the floor, and immediately prior to discharge. The pain scores for each patient were averaged.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Post-operative pain scores were not recorded for one participant in the Pneumoperitoneum pressure 6 mmHg group'}, {'type': 'SECONDARY', 'title': 'Operative Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pressure 6 mmHg', 'description': 'Pneumoperitoneum Pressure 6 mmHg\n\nPneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.'}, {'id': 'OG001', 'title': 'Pressure 15 mmHg', 'description': 'Pneumoperitoneum Pressure 15 mmHg\n\nPneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.'}], 'classes': [{'categories': [{'measurements': [{'value': '629.1', 'spread': '81.9', 'groupId': 'OG000'}, {'value': '629.4', 'spread': '83.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperatively', 'description': 'Average tidal volume (ml)', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Discharge Day (Post-operative Day 0 or 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pressure 6 mmHg', 'description': 'Pneumoperitoneum Pressure 6 mmHg\n\nPneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.'}, {'id': 'OG001', 'title': 'Pressure 15 mmHg', 'description': 'Pneumoperitoneum Pressure 15 mmHg\n\nPneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.'}], 'classes': [{'categories': [{'title': 'Discharged on Post-operative day 0', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Discharged on Post-operative day 1', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through discharge (post-operative day 0 or 1)', 'description': 'The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The post-operative discharge day was not recorded for one participant in each group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pressure 6 mmHg', 'description': 'Pneumoperitoneum Pressure 6 mmHg\n\nPneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.'}, {'id': 'FG001', 'title': 'Pressure 15 mmHg', 'description': 'Pneumoperitoneum Pressure 15 mmHg\n\nPneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '170 participants were consented/enrolled 31 participants were withdrawn prior to randomization (10 due to coronavirus-19 concerns; 9 due to principal investigator leaving the institution; 5 due to patient request; 3 due to change in eligibility; 3 due to resource availability; 1 at principal investigator request)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pressure 6 mmHg', 'description': 'Pneumoperitoneum Pressure 6 mmHg\n\nPneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.'}, {'id': 'BG001', 'title': 'Pressure 15 mmHg', 'description': 'Pneumoperitoneum Pressure 15 mmHg\n\nPneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.2', 'spread': '6.52', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '6.67', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '6.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-03', 'size': 312512, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-01T10:20', 'hasProtocol': True}, {'date': '2020-09-03', 'size': 134215, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-12-01T10:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'whyStopped': 'PI left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2018-08-10', 'resultsFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-17', 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Medication Use', 'timeFrame': 'Through 1 week postoperatively', 'description': 'The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.'}], 'secondaryOutcomes': [{'measure': 'Post Operative Pain Scores', 'timeFrame': 'Through discharge (post-operative day 0 or post-operative day 1)', 'description': 'Each participant was asked to rate their pain on a 0-10 scale, with higher numbers representing worse pain. Patients rated their pain at the following time points: in the post-anesthesia care unit (PACU) upon waking from anesthesia, at hours 4, 12, 16, and 20 after transfer to the floor, and immediately prior to discharge. The pain scores for each patient were averaged.'}, {'measure': 'Operative Ventilation', 'timeFrame': 'Intraoperatively', 'description': 'Average tidal volume (ml)'}, {'measure': 'Discharge Day (Post-operative Day 0 or 1)', 'timeFrame': 'Through discharge (post-operative day 0 or 1)', 'description': 'The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostatectomy', 'Robotic', 'Urology'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.', 'detailedDescription': 'The investigators to examine the impact of low pressure during robotic assisted laparoscopic prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit participants. The investigators hypothesize that a low insufflation pressure may provide an improvement in postoperative pain and abdominal distension in addition to potential physiologic benefits, and that these factors might then allow a shorter hospital stay. The investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as needed on an individual participant level. In order to determine whether this might allow earlier discharge when successful, the investigators began allowing for same-day discharge in participants meeting appropriate criteria. Having now demonstrated feasibility in over 300 consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Males with prostate cancer who are eligible and electing to undergo robotic assisted laparoscopic prostatectomy (RALP)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older\n2. Diagnosed with prostate cancer\n3. Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)\n\nExclusion Criteria:\n\n1. Age \\< 18\n2. Emergency surgery\n3. Patients with a significant preoperative dependence on narcotic medications\n4. Unable to give informed consent\n5. Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting\n6. Persons participating in any other research study involving an investigational drug or device or investigational surgical procedure that could interfere with the physiologic parameters being collected (for example, a study evaluating different anesthesia regimens that could confound study results)\n7. Non-English-speaking or reading'}, 'identificationModule': {'nctId': 'NCT03630393', 'acronym': 'Ultralow', 'briefTitle': 'Ultralow Versus Standard Pneumoperitoneum Pressure', 'organization': {'class': 'OTHER', 'fullName': 'OhioHealth'}, 'officialTitle': 'Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System', 'orgStudyIdInfo': {'id': '1306218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pressure 6 mmHg', 'description': 'Pneumoperitoneum Pressure 6 mmHg', 'interventionNames': ['Other: Pneumoperitoneum Pressure 6 mmHg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pressure 15 mmHg', 'description': 'Pneumoperitoneum Pressure 15 mmHg', 'interventionNames': ['Other: Pneumoperitoneum Pressure 15 mmHg']}], 'interventions': [{'name': 'Pneumoperitoneum Pressure 6 mmHg', 'type': 'OTHER', 'description': 'A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).', 'armGroupLabels': ['Pressure 6 mmHg']}, {'name': 'Pneumoperitoneum Pressure 15 mmHg', 'type': 'OTHER', 'description': 'A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).', 'armGroupLabels': ['Pressure 15 mmHg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43016', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dublin Methodist Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Ronney Abaza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OhioHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OhioHealth', 'class': 'OTHER'}, 'collaborators': [{'name': 'CONMED Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}