Staircase Nutritional Intervention for Elderly Patients Undergoing Spinal Fusion Surgery

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.

Conditions

• Nutritional Intervention
• Spinal Surgery
• Elderly
• Enhanced Recovery After Surgery

Interventions

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. 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

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Shibao Lu, MD · Xuanwu Hospital of Capital Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2027-05-31

Completion

2028-01-31