Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:51 AM
Study NCT ID:
NCT07440095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mortality Predictors in Patients 80+ After Major Abdominal Surgery: Role of Frailty and Physiological Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-Day Postoperative Mortality', 'timeFrame': 'From the date of surgery up to 30 days postoperatively', 'description': 'The occurrence of death from any cause within 30 days following the major abdominal surgical procedure. This will be assessed using hospital electronic records and, if necessary, through telephone follow-ups with patients or their relatives.'}], 'secondaryOutcomes': [{'measure': 'Modified Frailty Index (mFI-5) Score', 'timeFrame': 'Preoperative assessment (retrospective data from 2022-2025)', 'description': 'Assessment of patients\' frailty status using the Modified Frailty Index (mFI-5). The mFI-5 consists of 5 items: history of hypertension, diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, and functional status. Each item is assigned 1 point if present. The total score ranges from 0 to 5, where 0 represents "not frail" and 5 represents "severely frail." Higher scores indicate a higher degree of frailty and a worse clinical outcome'}, {'measure': 'Preoperative Serum Albumin Level', 'timeFrame': 'Preoperative laboratory values collected retrospectively from 2022-2025.', 'description': 'Evaluation of preoperative serum albumin levels (measured in g/dL) as an indicator of nutritional status and physiological reserve.'}, {'measure': 'Preoperative Serum Creatinine Level', 'timeFrame': 'Preoperative laboratory values collected retrospectively from 2022-2025.', 'description': 'Evaluation of preoperative serum creatinine levels (measured in mg/dL) to assess renal function as part of the physiological reserve'}, {'measure': 'Preoperative Hemoglobin Level', 'timeFrame': 'Preoperative laboratory values collected retrospectively from 2022-2025', 'description': 'Evaluation of preoperative hemoglobin levels (measured in g/dL) to assess the oxygen-carrying capacity and physiological reserve.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty', 'Postoperative Complications', 'Aged, 80 and Over', 'Abdomen Cancer']}, 'referencesModule': {'references': [{'pmid': '11253156', 'type': 'BACKGROUND', 'citation': 'Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.'}, {'pmid': '20510798', 'type': 'BACKGROUND', 'citation': 'Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.'}, {'pmid': '23395245', 'type': 'BACKGROUND', 'citation': 'Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to identify independent risk factors for 30-day mortality in patients aged 80 and over who have undergone major abdominal surgery. While traditional risk scoring systems often focus on chronic disease burden, they may not fully capture the biological decline associated with aging. This research specifically focuses on the predictive value of "frailty" and "physiological reserve" in determining surgical outcomes for this "old-old" patient population.\n\nIn this retrospective cohort study, data from approximately 200 patients treated between 2022 and 2025 will be analyzed. Frailty will be assessed using the Modified Frailty Index (mFI-5), and physiological reserve will be evaluated through preoperative laboratory markers such as albumin, creatinine, and lymphocyte counts. By determining how these factors influence postoperative mortality, the study aims to improve preoperative patient selection, enhance risk communication with families, and provide a basis for protective strategies like prehabilitation.', 'detailedDescription': 'As the global population ages, the "old-old" (aged 80 and over) patient group is increasingly encountered in surgical clinics. Major abdominal surgery in this demographic is categorized as high-risk due to both the severity of surgical trauma and the presence of multiple comorbidities. Traditional risk assessment tools often emphasize chronic disease burden but may fail to reflect the loss of biological resilience inherent in aging. "Frailty" has emerged as a critical parameter in predicting surgical outcomes, representing a state of reduced physiological reserve and increased vulnerability to stressors, independent of chronological age.\n\nThis retrospective study is designed to investigate the independent predictors of 30-day mortality in patients aged 80 and older who underwent major abdominal surgery (including gynecologic oncology, surgical oncology, and urologic oncology procedures) at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.\n\nMethodology and Data Collection:\n\nPatient data from the years 2022, 2023, 2024, and 2025 will be extracted from the hospital\'s electronic database. The study will include approximately 200 patients who meet the inclusion criteria.\n\nFrailty Assessment: The Modified Frailty Index (mFI-5) will be utilized to evaluate the frailty status of each patient. This index is a validated tool for retrospective studies and includes parameters such as functional status and history of specific comorbidities.\n\nPhysiological Reserve: This will be assessed using objective preoperative clinical and laboratory parameters, including serum albumin levels, creatinine, leukocyte/lymphocyte ratios, hemoglobin levels, and the American Society of Anesthesiologists (ASA) physical status score.\n\nOutcome Measure: The primary endpoint is 30-day postoperative mortality. If 30-day follow-up data is not available in the hospital records, patients or their relatives will be contacted via telephone to determine the survival status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of "old-old" patients (aged 80 years and older) who underwent major abdominal surgery at a tertiary oncology center (Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital) between January 2022 and December 2025. This population includes patients who received surgical interventions in the departments of surgical oncology, gynecologic oncology, and urologic oncology. The sample represents a high-risk geriatric group undergoing complex oncological or major abdominal procedures, where frailty and physiological reserve are critical factors for survival.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 80 years and older\n* Underwent major abdominal surgery between January 2022 and December 2025\n* Availability of at least 30 days of postoperative follow-up data\n* Complete medical records available in the hospital information system\n\nExclusion Criteria:\n\n* Patients under 80 years of age\n* Underwent surgical procedures other than major abdominal surgery\n* Missing or incomplete follow-up data within the first 30 days postoperatively\n* Insufficient data for the assessment of frailty (mFI-5) or physiological reserve parameters (e.g., missing preoperative laboratory values)'}, 'identificationModule': {'nctId': 'NCT07440095', 'briefTitle': 'Mortality Predictors in Patients 80+ After Major Abdominal Surgery: Role of Frailty and Physiological Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}, 'officialTitle': 'Mortality Predictors After Major Abdominal Surgery in Patients Aged 80 and Over: The Role of Frailty and Physiological Reserve', 'orgStudyIdInfo': {'id': '2026-02/31'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Major Abdominal Surgery and Frailty Assessment', 'type': 'OTHER', 'description': 'Retrospective evaluation of patients aged 80 and over who underwent major abdominal surgery (including surgical oncology, gynecologic oncology, and urologic oncology). The study involves the assessment of preoperative frailty using the Modified Frailty Index (mFI-5) and the analysis of physiological reserve through laboratory markers (albumin, creatinine, lymphocyte count, hemoglobin). The primary focus is to determine the impact of these factors on 30-day postoperative mortality.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Ankara', 'state': 'Yenimahalle', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Mustafa Kemal Şahin', 'role': 'CONTACT', 'email': 'mksahin@msn.com', 'phone': '05075800976'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To protect patient privacy and comply with institutional data protection policies'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist Doctor, Anesthesiology and Reanimation', 'investigatorFullName': 'Mustafa Kemal ŞAHİN', 'investigatorAffiliation': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}}}}