Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-03 @ 8:09 AM
Study NCT ID:
NCT02471612
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Analysis of APACHE II and P-POSSUM
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'debsanjay@gmail.com', 'phone': '+91-7763807101', 'title': 'Dr.Deb Sanjay Nag', 'organization': 'Tata Main Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Observational study. So no specific adverse effect because of the study.'}}, 'adverseEventsModule': {'timeFrame': 'The patients were followed up for the duration of admission and till at least 30 days after discharge or death (whichever was earlier).', 'eventGroups': [{'id': 'EG000', 'title': 'APACHE-2 Scoring', 'description': 'All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.', 'otherNumAtRisk': 157, 'otherNumAffected': 0, 'seriousNumAtRisk': 157, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'P-POSSUM', 'description': 'All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery', 'otherNumAtRisk': 157, 'otherNumAffected': 0, 'seriousNumAtRisk': 157, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the APACHE II and P-POSSUM Scoring Systems to Predict Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AUC Using APACHE II', 'description': 'All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.'}, {'id': 'OG001', 'title': 'AUC Using P-POSSUM', 'description': 'All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.965', 'groupId': 'OG000', 'lowerLimit': '0.928', 'upperLimit': '1.000'}, {'value': '0.989', 'groupId': 'OG001', 'lowerLimit': '0.974', 'upperLimit': '1.000'}]}]}], 'analyses': [{'pValue': '0.665', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Comparing the sensitivity of APACHE-II and P-POSSUM', 'groupDescription': 'Area under the curve (AUC) is used to measure the "size" of the prediction composed by the graphic display between the \'sensitivity\' and the \'1-specificity\' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \\> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \\< 0.60 is regarded as poor.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Participants will be followed for the duration of hospital stay (expected average of 30 days) and mortality was noted.All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II and P-POSSUM scoring systems on the day of surgery. Area under the curve (AUC) is used to measure the "size" of the prediction composed by the graphic display between the \'sensitivity\' and the \'1-specificity\' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \\> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \\< 0.60 is regarded as poor. For APACHE-II, a cut off score of \\>/=24 was determined; for P-POSSUM, a cut off score of \\>/= 63 was determined.', 'unitOfMeasure': 'probability of accurate prediction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients undergoing emergency laparotomy at Tata Main Hospital form December 2013 to November 2014 were scored with APACHE II \\& P-POSSUM scoring systems on the day of surgery. The patients were followed up till at least 30 days after discharge or death (during admission or within 30 days after discharge).'}, {'type': 'SECONDARY', 'title': 'Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Length of Stay', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were observed for their length of stay (LOS)'}], 'classes': [{'title': 'Surviving Patients', 'categories': [{'measurements': [{'value': '9.36', 'spread': '8.04', 'groupId': 'OG000'}]}]}, {'title': 'Patients who Died', 'categories': [{'measurements': [{'value': '14.91', 'spread': '15.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The mean duration of hospital stay or Length of Stay was recorded', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Postoperative Ventilator Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surviving Patients', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed ventilatory support postoperatively'}, {'id': 'OG001', 'title': 'Patients Who Died', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed ventilatory support postoperatively'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of patients needing post-operative ventilatory support', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Post Operative Inotropic Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surviving Patients', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the need for inotropic support during their stay..'}, {'id': 'OG001', 'title': 'Patients Who Died', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the need for inotropic support during their stay..'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of patients needing post-operative inotropic support', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Survived', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)'}, {'id': 'OG001', 'title': 'Patients Who Died', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Kidney Injury (AKI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Survived', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the Acute Kidney Injury'}, {'id': 'OG001', 'title': 'Patients Who Died', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the Acute Kidney Injury'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Acute Kidney Injury (AKI) was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group (2012) guidelines\n\n1. Increase in Serum Creatinine (S. Cr) by ≥0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours; OR\n2. Increase in S. Cr to ≥1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR\n3. Urine volume \\<0.5 ml/kg/h for 6 hours', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients Needing Re-exploration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Survived', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed re-exploration during the post-operative period.'}, {'id': 'OG001', 'title': 'Patients Who Died', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed re-exploration during the post-operative period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of patients needing return to the operation theater for surgery for the same pathology or any other complication arising out of the initial surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients Who Underwent Emergency Exploratory Laparotomy', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the P-POSSUM Score APACHE-II'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'All who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, India who met the inclusion criteria were included in the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Emergency Laparotomy', 'description': 'All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the APACHE-2 Score \\& P-POSSUM Score'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18- 20 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': '21-40 years', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': '41-60 years', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': '61-80 years', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': '> 80years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'All patients above 18 years age were included in the study', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-06', 'studyFirstSubmitDate': '2015-06-09', 'resultsFirstSubmitDate': '2015-12-20', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-17', 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the APACHE II and P-POSSUM Scoring Systems to Predict Mortality', 'timeFrame': '30 days', 'description': 'Participants will be followed for the duration of hospital stay (expected average of 30 days) and mortality was noted.All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II and P-POSSUM scoring systems on the day of surgery. Area under the curve (AUC) is used to measure the "size" of the prediction composed by the graphic display between the \'sensitivity\' and the \'1-specificity\' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \\> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \\< 0.60 is regarded as poor. For APACHE-II, a cut off score of \\>/=24 was determined; for P-POSSUM, a cut off score of \\>/= 63 was determined.'}], 'secondaryOutcomes': [{'measure': 'Length of Stay (LOS)', 'timeFrame': '30 days', 'description': 'The mean duration of hospital stay or Length of Stay was recorded'}, {'measure': 'Need for Postoperative Ventilator Support', 'timeFrame': '30 days', 'description': 'Number of patients needing post-operative ventilatory support'}, {'measure': 'Need for Post Operative Inotropic Support', 'timeFrame': '30 days', 'description': 'Number of patients needing post-operative inotropic support'}, {'measure': 'Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)', 'timeFrame': '30 days', 'description': 'Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment'}, {'measure': 'Number of Participants With Acute Kidney Injury (AKI)', 'timeFrame': '30 days', 'description': 'Acute Kidney Injury (AKI) was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group (2012) guidelines\n\n1. Increase in Serum Creatinine (S. Cr) by ≥0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours; OR\n2. Increase in S. Cr to ≥1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR\n3. Urine volume \\<0.5 ml/kg/h for 6 hours'}, {'measure': 'Patients Needing Re-exploration', 'timeFrame': '30 days', 'description': 'Number of patients needing return to the operation theater for surgery for the same pathology or any other complication arising out of the initial surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['External Causes of Morbidity and Mortality']}, 'referencesModule': {'references': [{'pmid': '31531317', 'type': 'RESULT', 'citation': 'Nag DS, Dembla A, Mahanty PR, Kant S, Chatterjee A, Samaddar DP, Chugh P. Comparative analysis of APACHE-II and P-POSSUM scoring systems in predicting postoperative mortality in patients undergoing emergency laparotomy. World J Clin Cases. 2019 Aug 26;7(16):2227-2237. doi: 10.12998/wjcc.v7.i16.2227.'}]}, 'descriptionModule': {'briefSummary': 'To compare APACHE II and P-POSSUM scoring system in emergency laparotomy.', 'detailedDescription': 'To compare APACHE II and P-POSSUM scoring system in predicting postoperative mortality in patients undergoing emergency laparotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 will be included in the study. All patients will be scored with APACHE II and P-POSSUM scoring systems on the day of surgery.The patients will be followed up till discharge, death or 30 days postoperatively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients above 18 years of age undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 will be included in the study.\n\nExclusion Criteria:\n\n* Patients willingly seeking referral to a different hospital'}, 'identificationModule': {'nctId': 'NCT02471612', 'briefTitle': 'Comparative Analysis of APACHE II and P-POSSUM', 'organization': {'class': 'OTHER', 'fullName': 'Tata Main Hospital'}, 'officialTitle': 'Comparative Analysis of APACHE II and P-POSSUM Scoring Systems in Predicting Postoperative Mortality in Patients Undergoing Emergency Laparotomy', 'orgStudyIdInfo': {'id': '201-26104-132-108296'}}, 'contactsLocationsModule': {'locations': [{'zip': '831001', 'city': 'Jamshedpur', 'state': 'Jharkhand', 'country': 'India', 'facility': 'Tata Main Hospital', 'geoPoint': {'lat': 22.80278, 'lon': 86.18545}}], 'overallOfficials': [{'name': 'Ankur Dembla, DA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tata Main Hospital, Jamshedpur, India'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Main Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Specialist', 'investigatorFullName': 'Dr.Deb Sanjay Nag', 'investigatorAffiliation': 'Tata Main Hospital'}}}}