Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-29 @ 5:33 PM
Study NCT ID:
NCT05583292
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2022-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mortality Predictions With Scorring Indices in Gastrointestinal Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C070385', 'term': '4-azidosalicylic acid-phosphatidylserine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of mortality', 'timeFrame': '6 months after surgery', 'description': 'death depending on the operation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASA-PS', 'SORT', 'Sarcopenia', 'Mortality', 'Morbidity'], 'conditions': ['Gastrointestinal Tumours']}, 'descriptionModule': {'briefSummary': 'The ASA-PS, SORT and Sarcopenia scores of the patients who will undergo surgery for a gastrointestinal tumor will be recorded. Thus, the correlation between preoperative indices and mortality/morbidity will be evaluated.', 'detailedDescription': 'ASA-PS values of patients who are planned to be operated due to gastrointestinal tumor will be recorded, then SORT (The Surgical Outcome Risk Tool) values will be calculated from sortsurgery.com. Sarcopenia measurements will be made by the radiologist from the abdomen CT at the L-3 level.\n\nThe pathology results of the patients will be recorded. Morbidity and mortality rates will be recorded in the short and long term.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing gastrointestinal tumor surgery in a tertiary madical center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* operation for gastrointestinal tumors\n\nExclusion Criteria:\n\n* patient rejection'}, 'identificationModule': {'nctId': 'NCT05583292', 'briefTitle': 'Mortality Predictions With Scorring Indices in Gastrointestinal Tumours', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'The Effectiveness of ASA, SORT and Sarcopenia Indices in Estimating Mortality and Morbidity in Gastrointestinal Tumour Surgery', 'orgStudyIdInfo': {'id': '01f'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ASA-PS', 'type': 'OTHER', 'description': 'The American Society of Anesthesiologists classification of physical status (ASA PS) is a scale consisting of 6 classes showing the preoperative comorbidity of the patient.'}, {'name': 'SORT', 'type': 'OTHER', 'description': 'Surgical outcome risk tool (SORT) is a scale used to estimate patient preoperative mortality/ morbidity, measured from sortsurgery.com.'}, {'name': 'Sarcopenia', 'type': 'OTHER', 'description': 'Sarcopenia represents a loss of muscle strength and mass in older individuals and people who have tumors. Sarcopenia score is valuable in predicting preoperative mortality/ morbidity'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof. Dr. Cemil Taşcıoğlu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'fethi gültop, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Anesthesiology and Reanimation Specialist, Principal Investigator, Lecturer MD', 'investigatorFullName': 'Fethi Gultop', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}