[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654617":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":38,"studyPopulation":39,"armGroups":40,"interventions":51,"overallOfficials":61,"centralContacts":65,"locations":74,"responsibleParty":89,"collaborators":35,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":35,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":35,"enrollmentInfo":101,"targetDuration":35,"studyType":104,"phases":35,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":115,"whyStopped":35,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Kocaeli City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of postoperative complication","According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.","Up to 30 days post-operative",[14],{"measure":15,"description":16,"timeFrame":17},"Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)","Change in neutrophil-to-lymphocyte ratio from preoperative baseline to postoperative days 1, 3, and 5","Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative",[19,22,26,30],{"measure":20,"description":21,"timeFrame":17},"Changes in C-reactive protein (CRP) levels during the postoperative period compared with baseline values","Change in C-reactive protein from preoperative baseline to postoperative days 1, 3, and 5.",{"measure":23,"description":24,"timeFrame":25},"Rate of postoperative delirium","Occurrence of postoperative delirium assessed daily using the Confusion Assessment Method.","Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.",{"measure":27,"description":28,"timeFrame":29},"Comparison of length of stay in hospital","Hospital length of stay measured in days from surgery to hospital discharge.","From date of surgery until date of hospital discharge, assessed up to 3 months",{"measure":31,"description":32,"timeFrame":33},"Comparison of changes in hand grip strength","Change in handgrip strength from the preoperative assessment to the pre-discharge assessment","Baseline, pre-discharge",{"allocation":35,"interventionModel":35,"interventionModelDescription":35,"primaryPurpose":35,"observationalModel":36,"timePerspective":37,"maskingInfo":35},null,"COHORT","PROSPECTIVE","This prospective, observational, analytical cohort study will be conducted at the General Surgery Clinic of Kocaeli City Hospital. The study will include patients aged 60 years and older who have gastric cancer and are scheduled for elective radical gastrectomy. A total of 328 patients are planned to be enrolled.\n\nPreoperative assessment will include multidimensional frailty-related parameters, including the modified Frailty Index-11 (mFI-11), Montreal Cognitive Assessment (MoCA), handgrip strength, Nutritional Risk Screening 2002 (NRS-2002), Prognostic Nutritional Index (PNI), and skeletal muscle characteristics assessed on computed tomography at the L3 level. Baseline neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP) levels will also be recorded.\n\nIntraoperative data will include surgical approach, operative duration, and intraoperative blood loss. Postoperatively, NLR and CRP will be assessed on postoperative days 1, 3, and 5. Delirium will be evaluated using the Confusion Assessment Method (CAM). Postoperative complications will be recorded according to the Clavien-Dindo classification, together with hospital length of stay and handgrip strength before discharge.\n\nThe primary purpose of the study is to evaluate the association between multidimensional frailty phenotypes and postoperative outcomes and biological recovery in older patients undergoing gastric cancer surgery. The study will also investigate whether the surgical approach is associated with differences in biological recovery among patients with different frailty profiles.","The study population will consist of patients aged 60 years and older with gastric cancer who are scheduled for elective radical gastrectomy at the General Surgery Clinic of Kocaeli City Hospital. Eligible participants will be enrolled prospectively according to the predefined inclusion and exclusion criteria. A total of 328 participants are planned to be included.",[41,46],{"label":42,"type":35,"description":43,"interventionNames":44},"Laparoscopic Surgery","Patients undergoing elective radical gastrectomy through a laparoscopic approach. The surgical approach is determined by routine clinical practice and is not assigned by the study.",[45],"Procedure: Laparoscopic Gastrectomy",{"label":47,"type":35,"description":48,"interventionNames":49},"Open Surgery","Patients undergoing elective radical gastrectomy through an open approach. The surgical approach is determined by routine clinical practice and is not assigned by the study.",[50],"Procedure: Open Gastrectomy",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":35},"PROCEDURE","Laparoscopic Gastrectomy","Elective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care. The surgical approach is not assigned by the study",[42],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":35},"Open Gastrectomy","Elective radical gastrectomy performed using an open approach as part of routine clinical care. The surgical approach is not assigned by the study",[47],[62],{"name":63,"affiliation":5,"role":64},"Adem Yuksel, Assoc.Prof.","PRINCIPAL_INVESTIGATOR",[66,70],{"name":63,"role":67,"phone":68,"phoneExt":35,"email":69},"CONTACT","5053455259","drademyuksel@gmail.com",{"name":71,"role":67,"phone":72,"phoneExt":35,"email":73},"Sumru Atak, M.D.","5546664272","berilsumru@gmail.com",[75],{"facility":5,"status":35,"city":76,"state":77,"zip":35,"country":78,"countryCode":35,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Kocaeli","İZMİT","Turkey (Türkiye)",{"type":80,"coordinates":81},"Point",[82,83],27.51145,39.62497,{"lat":83,"lon":82},[86,88],{"name":63,"role":67,"phone":87,"phoneExt":35,"email":69},"+90 505 345 52 59",{"name":63,"role":64,"phone":35,"phoneExt":35,"email":35},{"type":64,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Adem Yüksel","Associate Professor","100654617","frailty-immunonutrition-surgery-type-and-biologic-recovery-in-elderly-gastric-cancer-100654617",false,"NCT07803159","Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer","The Effects of Multidimensional Frailty Phenotypes, Immunonutritional Status, and Surgical Approach on Biological Recovery in Elderly Patients Undergoing Gastric Cancer Surgery: A Prospective Observational Study","Inclusion Criteria:\n\n* Age 60 years or older.\n* Histopathological or endoscopic diagnosis of gastric cancer.\n* Planned elective radical gastrectomy.\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Stage IV metastatic gastric cancer.\n* Requirement for emergency surgery.\n* Severe neurological or psychiatric disease preventing completion of cognitive testing.\n* Incomplete clinical data.\n* Refusal to participate in the study.","ALL","60 Years",{"count":102,"type":103},328,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study will evaluate the effects of multidimensional frailty phenotypes, immunonutritional status, and surgical approach on biological recovery in patients aged 60 years and older undergoing surgery for gastric cancer. Preoperative assessment will include physical and cognitive frailty, nutritional status, handgrip strength, and skeletal muscle characteristics on computed tomography. Patients will be followed prospectively during the perioperative period, including assessment of inflammatory markers, postoperative complications, delirium, hospital length of stay, and functional recovery. The study aims to determine whether multidimensional frailty and immunonutritional factors are associated with postoperative outcomes and whether surgical approach influences biological recovery in older patients with gastric cancer. A total of 328 patients are planned to be included at Kocaeli City Hospital.",[107,108],"Gastric Cancer","Gastric Adenocarcinoma",[110,111,112,113,114],"gastric cancer","fraility","immunonutrition","gastrectomy","cognitive function","NOT_YET_RECRUITING","2026-09-02",{"date":118,"type":119},"2026-09-03","ACTUAL",{"date":121,"type":103},"2026-09",{"date":123,"type":103},"2028-08",{"name":5,"class":6},1]