[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597296":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":26,"responsibleParty":43,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":26,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":26,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":26},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Staircase Nutritional Intervention Group","EXPERIMENTAL","Fourteen days before admission, different nutritional supplements will be provided according to whether the patient has diabetes and their nutritional status. Patients without diabetes who are malnourished should take enteral nutrition powder mixture three times a day, with each dose providing 265 kCal of energy. Patients without diabetes but at risk of malnutrition should take enteral nutrition powder mixture twice a day. Patients with diabetes who are malnourished should take low - sugar whole - protein enteral nutrition powder three times a day, with each dose providing 250 kCal of energy. Patients with diabetes and at risk of malnutrition should take low - sugar whole - protein enteral nutrition powder twice a day.\n\nDuring the peri - operative period, a strict 6 - hour fasting of solid food and 2 - hour fasting of clear liquid before surgery is implemented. Two hours after surgery, all patients should take multi - dimensional carbohydrates, which provide 115 kCal of energy. Four h",[13],"Dietary Supplement: Staircase Nutritional Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard ERAS Diet Management Group","ACTIVE_COMPARATOR","Only nutritional education is provided to patients before admission, without any specific nutritional supplements. During the peri - operative period, patients are required to fast from food and water for 8 hours before surgery. Six hours after surgery, patients are allowed to drink water. They can start consuming liquid food after passing gas from the anus. No specific energy - containing nutritional supplements are given during this period. A nutritional guidance manual is distributed to patients upon discharge, and there are no targeted nutritional interventions or follow - up measures related to energy intake subsequently.",[19],"Dietary Supplement: Standard ERAS Diet Management Group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Staircase Nutritional Intervention","Fourteen days before admission, different nutritional supplements will be provided according to whether the patient has diabetes and their nutritional status. Patients without diabetes who are malnourished should take enteral nutrition powder mixture three times a day, with each dose providing 265 kCal of energy. Patients without diabetes but at risk of malnutrition should take enteral nutrition powder mixture twice a day. Patients with diabetes who are malnourished should take low - sugar whole - protein enteral nutrition powder three times a day, with each dose providing 250 kCal of energy. Patients with diabetes and at risk of malnutrition should take low - sugar whole - protein enteral nutrition powder twice a day.\n\nDuring the peri - operative period, a strict 6 - hour fasting of solid food and 2 - hour fasting of clear liquid before surgery is implemented. Two hours after surgery, all patients should take multi - dimensional carbohydrates, which provide 115 kCal of energy. Four ho",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"affiliation":32,"role":33},"Shibao Lu, MD","Xuanwu Hospital of Capital Medical University","STUDY_CHAIR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","+8615804084262","2862075852@qq.com",{"name":40,"role":36,"phone":41,"phoneExt":26,"email":42},"Di Han, PhD","+8619522275169","dh693874@gmail.com",{"type":44,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100597296","staircase-nutritional-intervention-for-elderly-patients-undergoing-spinal-fusion-surgery-100597296",false,"NCT07056647","Staircase Nutritional Intervention for Elderly Patients Undergoing Spinal Fusion Surgery","A Prospective Multicenter Randomized Controlled Trial of a Staircase Nutritional Intervention Strategy Versus Conventional ERAS Diet Management for Elderly Patients Undergoing Spinal Fusion Surgery","SNIEPUSFS","Inclusion Criteria:\n\n* Age and Gender: Aged ≥ 75 years, regardless of gender. Surgery Type: Scheduled for elective spinal fusion surgery, including but not limited to lumbar, thoracic, and cervical spinal fusion surgeries. The surgeries are aimed at treating spinal degenerative diseases (such as lumbar disc herniation, lumbar spinal stenosis, etc.), spinal trauma, spinal deformities, etc.\n\nNutritional Status: Willing and able to cooperate with nutritional assessments (such as Mini - Nutritional Assessment, MNA), and patients with any level of nutritional risk are included.\n\nPhysical Condition: American Society of Anesthesiologists (ASA) physical status classification Ⅰ - Ⅲ, meaning the physical condition is relatively tolerable for surgery, without severe failure of important organs such as the heart, lungs, liver, and kidneys, and without uncontrolled severe hypertension, diabetic ketoacidosis, and other acute complications.\n\nCognitive and Communication Ability: Possessing basic cognitive and communication abilities, being able to understand the purpose, process, and relevant requirements of the study, and signing a written informed consent form.\n\nLife Expectancy: With a life expectancy of more than 1 year to facilitate long - term postoperative follow - up and assessment.\n\nExclusion Criteria:\n\n* Severe Underlying Diseases: Presence of severe heart failure (New York Heart Association functional class Ⅳ), end - stage liver disease (such as decompensated liver cirrhosis with severe ascites, hepatic encephalopathy, etc.), end - stage renal disease (requiring maintenance dialysis treatment), end - stage malignant tumors, and other serious underlying diseases that severely affect life and health and recovery.\n\nPsychiatric and Neurological Diseases: Suffering from severe mental illnesses (such as schizophrenia, major depressive disorder in the acute phase and unable to cooperate with the study), Alzheimer's disease and unable to understand the content of the study, and serious neurological diseases (such as long - term bedridden patients with severe stroke and impaired consciousness).\n\nContraindications to Nutritional Supplements: Allergic to the components of the nutritional supplements involved in the study (such as enteral nutrition powder mixture, low - sugar whole - protein enteral nutrition powder, etc.) or having severe intolerance.\n\nRecent Special Situations: Having a history of severe trauma or major surgery (other than the planned spinal fusion surgery) in the past 3 months; having a history of severe gastrointestinal diseases such as gastrointestinal bleeding and intestinal obstruction in the past 1 month.\n\nOthers: Currently participating in other clinical trials that may affect the results of this study; having insurmountable compliance problems (such as failure to take nutritional supplements on time, refusal of follow - up, etc.).","ALL","75 Years",{"count":56,"type":57},88,"ESTIMATED","INTERVENTIONAL",[60],"NA","The goal of this prospective multicenter randomized controlled clinical trial is to evaluate the efficacy of a staircase nutritional intervention in reducing postoperative complications and improving long-term functional recovery in elderly patients aged ≥75 years scheduled for spinal fusion surgery. The main questions it aims to answer are:\n\n1. Does the staircase nutritional intervention reduce the 30-day postoperative complication rate, as measured by the Comprehensive Complication Index (CCI), compared to conventional ERAS diet management?\n2. Does the staircase nutritional intervention improve 1-year functional recovery, as assessed by Oswestry\u002FNeck Disability Index (ODI\u002FNDI) and health-related quality of life (EQ-5D), compared to conventional ERAS diet management?\n\nResearchers will compare the intervention group receiving MNA - based staircase nutritional intervention (including 14-day preadmission oral nutritional supplementation, perioperative personalized nutritional support, and postdischarge continuous management) combined with surgery-specific prehabilitation training to the control group receiving conventional ERAS diet management to see if the former leads to better clinical outcomes and long-term functional recovery.\n\nParticipants will\n\nUndergo randomization: Be randomly assigned to either the intervention group or the control group.\n\nReceive assigned interventions:\n\nControl group: Receive conventional ERAS diet management, including preadmission nutritional education and early postoperative oral intake.\n\nIntervention group: Undergo MNA - based staircase nutritional intervention and surgery-specific prehabilitation training.\n\nParticipate in follow-up: Complete short-term (within 90 days postoperatively) and long-term (6 and 12 months postoperatively) follow-up assessments, including laboratory tests, functional evaluations, and satisfaction surveys.",[63,64,65,66],"Nutritional Intervention","Spinal Surgery","Elderly","Enhanced Recovery After Surgery","NOT_YET_RECRUITING","2025-06-29",{"date":70,"type":71},"2025-07-09","ACTUAL",{"date":73,"type":57},"2025-07-01",{"date":75,"type":57},"2028-01-31",{"name":5,"class":6}]