Staircase Nutritional Intervention for Elderly Patients Undergoing Spinal Fusion Surgery

NCT07056647 | Not Yet Recruiting

• 1 other identifier: xuanwu-ESN
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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?

Conditions

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

Outcome Measures

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.

  up to 90 days after surgery

Secondary Outcomes (10)

• Pain level

  up to 90 days after surgery

• Physiological function recovery

  up to 90 days after surgery

• Serum Albumin Levels Measured Postoperatively

  up to 90 days after surgery

• Health-related quality of life

  up to 90 days after surgery

• Physical function

  up to 90 days after surgery

Other Outcomes (8)

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

  6 and 12 months postoperatively

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

  6 and 12 months postoperatively

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

  6 and 12 months postoperatively

Study Arms (2)

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. 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 h

Dietary Supplement: Staircase Nutritional Intervention

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.

Dietary Supplement: Standard ERAS Diet Management Group

Interventions

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

Staircase Nutritional Intervention Group

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.

Standard ERAS Diet Management Group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Nutritional 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.
• Physical 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.
• Cognitive 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.
• Life Expectancy: With a life expectancy of more than 1 year to facilitate long - term postoperative follow - up and assessment.

You may not qualify if:

• 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.
• Psychiatric 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).
• Contraindications 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.
• Recent 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.
• Others: 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.).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Related Publications (2)

• Millrose M, Schmidt W, Krickl J, Ittermann T, Ruether J, Bail HJ, Gesslein M. Influence of Malnutrition on Outcome after Hip Fractures in Older Patients. J Pers Med. 2023 Jan 3;13(1):109. doi: 10.3390/jpm13010109.

  PMID: 36675770 RESULT

• Yap YY, Tan SH, Choon SW. Elderly's intention to use technologies: A systematic literature review. Heliyon. 2022 Jan 13;8(1):e08765. doi: 10.1016/j.heliyon.2022.e08765. eCollection 2022 Jan.

  PMID: 35128090 RESULT

Study Officials

• Shibao Lu, MD

  Xuanwu Hospital of Capital Medical University

  STUDY CHAIR

Central Study Contacts

Shibao Lu, MD

CONTACT

+8615804084262; 2862075852@qq.com

Di Han, PhD

CONTACT

+8619522275169; dh693874@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 9, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share