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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Staircase Nutritional Intervention

    Dietary supplement

    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

    Dietary supplement

    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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Staircase Nutritional Intervention GroupExperimental treatment 1 intervention
Group B: Standard ERAS Diet Management GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comprehensive Complication Index (CCI)

The primary outcome is the Comprehensive Complication Index (CCI), a continuous scale (0-100 points, where 100 indicates death due to complications) that integrates all complications and their severity based on the Clavien-Dindo classification system. Postoperative complications will be recorded up to 90 days post-surgery (definitions in Appendix 1), with severity scored using the Clavien-Dindo system. CCI will be calculated using an online calculator (http://www.assessurgery.com). Previous studies have validated CCI as an effective measure of postoperative morbidity, demonstrating greater comprehensiveness and sensitivity than traditional metrics (e.g., overall complication rate or severe complication rate) for surgical research endpoints.

Time frame
up to 90 days after surgery

Secondary outcomes

1

Pain level

The Visual Analogue Scale (VAS) is a widely used tool to measure pain intensity. It consists of a 10-centimeter horizontal line, with endpoints labeled "no pain" (0) and "worst possible pain" (10). During the assessment, patients are asked to mark a point on the line that corresponds to their current pain level. This simple yet effective method provides a quantitative measure of pain, allowing for consistent monitoring and comparison of pain intensity over time.

Time frame
up to 90 days after surgery
2

Physiological function recovery

Sum of days to first defecation, first urination, and first ambulation postoperatively.

Time frame
up to 90 days after surgery
3

Serum Albumin Levels Measured Postoperatively

Serum albumin is a protein produced by the liver and is an important marker of nutritional status and overall health. To measure serum albumin levels, a blood sample is drawn and analyzed in a clinical laboratory using techniques such as spectrophotometry. Normal serum albumin levels typically range from 3.5 to 5.0 grams per deciliter (g/dL). In the postoperative period, monitoring serum albumin helps assess a patient's recovery, as low levels may indicate poor nutrition, inflammation, or other complications that can delay healing.

Time frame
up to 90 days after surgery
4

Health-related quality of life

Evaluated using the EuroQol five-dimension scale (EQ-5D, 0 = poorest health, 100 = best health).

Time frame
up to 90 days after surgery

Other outcomes

1

Long-term follow-up of Postoperative Pain Level Measured by Visual Analogue Scale (VAS)

The pain level is evaluated using the Visual Analogue Scale (VAS), a 10-centimeter horizontal line with endpoints labeled "no pain" (0) and "worst possible pain" (10). Patients mark a point corresponding to their current pain intensity at follow-up visits, quantifying pain to monitor changes over time.

Time frame
6 and 12 months postoperatively
2

Long-term follow-up of functional disability assessment using Oswestry/NDI Index

Functional disability is assessed with the Oswestry Disability Index (ODI) for lumbar patients and Neck Disability Index (NDI) for cervical patients. Self-report questionnaires include daily activities (e.g., personal care, walking), rated 0 (no disability) to 5 (complete disability). Total scores (as percentages) reflect disability severity and treatment impact.

Time frame
6 and 12 months postoperatively
3

Long-term follow-up of ADL and IADL scales assessment of activities of daily living

ADL (basic self-care: eating, dressing) and IADL (complex skills: shopping, finance) scales evaluate independent living abilities. Scores at follow-up visits determine recovery and surgical impact on daily function.

Time frame
6 and 12 months postoperatively
4

Long-term follow-up of quality of life evaluation by EQ-5D score

The EQ-5D scale assesses mobility, self-care, pain, and mental state (5 dimensions, each 0-3 severity levels). A visual analog health rating (0-100) is integrated to generate scores, with higher values indicating better quality of life.

Time frame
6 and 12 months postoperatively

Locations

This trial has no locations.

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