Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT05890820
Status:
UNKNOWN
Last Update Posted:
2023-06-06
First Post:
2023-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Thoracic Surgery Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FFMI - Fat-Free Mass Index', 'timeFrame': '24 hours', 'description': 'FFMI is an abbreviation for lean mass index. It defines the amount of your muscle mass relative to height and weight. The FFMI is part of the well-known and similar BMI family of body indexes. The effect of FFMI values on postoperative patient stay, intensive care unit stay, complications and postoperative mobilization time in lung cancer patients will be evaluated. Each patient will be evaluated by measuring the preoperative FFMI value 24 hours before.'}], 'secondaryOutcomes': [{'measure': 'BMI (Body Mass Index)', 'timeFrame': '24 hours', 'description': "BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass. The effect of BMI values on postoperative patient stay, intensive care unit stay, complications and postoperative mobilization time in lung cancer patients will be evaluated. Each patient will be evaluated by measuring the preoperative BMI value 24 hours before."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Nutrition, Healthy', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'Preoperative evaluation of nutritional status in geriatric patients with lung cancer and implementation of these practices in elective patients are very important in terms of reducing postoperative complications and accelerating hospital discharge. For this purpose, many nutritional assessments and measurements are used. Our aim in this study was to evaluate the relationship between preoperative nutritional status and postoperative pulmonary complications in patients undergoing thoracic surgery for geriatric lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 65 years of age with lung malignancy and undergoing thoracic surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 65 years of age\n* Lung Cancer\n* Patients undergoing thoracic surgery\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Patients with a diagnosis of hematological malignancy\n* Patients with missing data required for research'}, 'identificationModule': {'nctId': 'NCT05890820', 'briefTitle': 'The Effect of Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Thoracic Surgery Cases', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Ataturk Sanatorium Training and Research Hospital'}, 'officialTitle': 'Evaluation of the Effect of Preoperative Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Patients Who Underwent Lung Resection for Malignancy, a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'E-53610172-799-207700439'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Preoperative nutritional assessment', 'type': 'OTHER', 'description': 'Preoperative nutritional assessment and postoperative pulmonary complications'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06290', 'city': 'Ankara', 'state': 'Keçioren', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'M. Ozgur Cirik, Assoc. Prof', 'role': 'CONTACT'}], 'facility': 'Ankara Atatürk Sanatoryum Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Mustafa Özgür Cirik Cirik, Assoc Prof', 'role': 'CONTACT', 'email': 'dr.ozgurr@hotmail.com', 'phone': '903123677235'}, {'name': 'Ali Alagöz, Full Prof', 'role': 'CONTACT', 'email': 'mdalagoz@gmail.com', 'phone': '903123677235'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Ataturk Sanatorium Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Proffessor', 'investigatorFullName': 'Mustafa Özgür Cirik', 'investigatorAffiliation': 'Ankara Ataturk Sanatorium Training and Research Hospital'}}}}