Staircase Nutritional Intervention for Elderly Patients Undergoing Spinal Fusion Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Staircase Nutritional Intervention
- Standard ERAS Diet Management Group
Treatment groups
88 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov