Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2026-04-18 @ 7:42 AM
Study NCT ID:
NCT03216694
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2017-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2017-07-11', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause postoperative morbidity', 'timeFrame': '30 days', 'description': 'Classified using Esophageal Complications Consensus Group (ECCG) definitions \\[1\\] and graded using Clavien-Dindo severity classification \\[2\\].'}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary complications', 'timeFrame': '30 days', 'description': 'Classified using ECCG definitions and graded using Clavien-Dindo severity classification.'}, {'measure': 'Non-cardiopulmonary complications', 'timeFrame': '30 days', 'description': 'Classified using ECCG definitions and graded using Clavien-Dindo severity classification.'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'All cause mortality.'}, {'measure': 'Mortality', 'timeFrame': '90 days', 'description': 'All cause mortality.'}, {'measure': 'Pneumonia', 'timeFrame': '30 days', 'description': 'Classified using ECCG definitions and graded using Clavien-Dindo severity classification.'}, {'measure': 'Atrial fibrillation', 'timeFrame': '30 days', 'description': 'Classified using ECCG definitions and graded using Clavien-Dindo severity classification.'}, {'measure': 'Anastomotic leak', 'timeFrame': '30 days', 'description': 'Classified using ECCG definitions and graded using Clavien-Dindo severity classification.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oesophageal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/25607756', 'label': '\\[1\\]'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/15273542', 'label': '\\[2\\]'}]}, 'descriptionModule': {'briefSummary': 'A retrospective hospital-based cohort study of the association between preoperative cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity following oesophagectomy.', 'detailedDescription': 'The aim of this study is to examine the correlations between preoperative CPEX variables (VO2max and Anaerobic Threshold) and 30 day postoperative all cause morbidity in a sample large enough to allow (should significant associations exist) calculation of a threshold value. Secondary aims are to examine associations between the VO2max, AT and cardiopulmonary, non-cardiopulmonary complications as well as specific complications (atrial fibrillation, pneumonia, and anastomotic leak) as well as 30 and 90 day mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that underwent oeosphagectomy at the Norfolk and Norwich Hospital between September 2011 to March 2017', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ni. male and female ii. underwent an oesophagectomy iii. completed a pre-operative CPEX test\n\nExclusion Criteria:\n\ni. patients that were unable to complete a full CPEX test ii. emergency or palliative surgery iii. pharyngolaryngo-oesophagectomy iv. oesophagectomy and gastrectomy'}, 'identificationModule': {'nctId': 'NCT03216694', 'briefTitle': 'The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of East Anglia'}, 'officialTitle': 'The Association Between Preoperative Cardiopulmonary Exercise Test Variables and Short-term Postoperative Morbidity Following Oesophagectomy: a Hospital-based Cohort Study', 'orgStudyIdInfo': {'id': '222793'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiopulmonary exercise testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Aerobic fitness measured using a cycle ergometer and metabolic cart'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NR4 7UY', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of East Anglia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}