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Staircase Nutritional Intervention for Elderly Patients Undergoing Spinal Fusion Surgery
Sponsor: Xuanwu Hospital, Beijing
Summary
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: 1. 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? 2. Does the staircase nutritional intervention improve 1-year functional recovery, as assessed by Oswestry/Neck Disability Index (ODI/NDI) and health-related quality of life (EQ-5D), compared to conventional ERAS diet management? Researchers 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. Participants will Undergo randomization: Be randomly assigned to either the intervention group or the control group. Receive assigned interventions: Control group: Receive conventional ERAS diet management, including preadmission nutritional education and early postoperative oral intake. Intervention group: Undergo MNA - based staircase nutritional intervention and surgery-specific prehabilitation training. Participate 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.
Official title: A Prospective Multicenter Randomized Controlled Trial of a Staircase Nutritional Intervention Strategy Versus Conventional ERAS Diet Management for Elderly Patients Undergoing Spinal Fusion Surgery
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2025-07-01
Completion Date
2028-01-31
Last Updated
2025-07-09
Healthy Volunteers
No
Interventions
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. During 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
Standard ERAS Diet Management Group
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.