Staircase Nutritional Intervention for Elderly Patients Undergoing Spinal Fusion Surgery
Launched by XUANWU HOSPITAL, BEIJING · Jun 29, 2025
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a special nutrition plan can help people aged 75 and older recover better after spinal fusion surgery, which is an operation to fix problems in the spine. The researchers want to see if this “staircase nutritional intervention”—a program that starts with nutritional supplements before surgery, continues with personalized nutrition during the hospital stay, and includes ongoing support after leaving the hospital—can reduce complications within 30 days after surgery and improve how well patients function and feel up to one year later. They will compare this approach to the usual diet care used in enhanced recovery programs.
People who are 75 years or older and scheduled for elective spinal fusion surgery may be eligible if they are generally healthy enough for surgery, able to understand the study, and willing to follow nutrition assessments and plans. Participants will be randomly placed into two groups: one will receive the special nutrition program plus tailored exercise before surgery, and the other will follow the standard diet care. Everyone will be closely followed for up to a year after surgery with tests and surveys to check their recovery, health, and satisfaction. This study aims to find better ways to support older adults through spinal surgery and help them get back to their daily lives as smoothly as possible.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.).
About Xuanwu Hospital, Beijing
Xuanwu Hospital, located in Beijing, is a leading clinical research institution renowned for its commitment to advancing medical knowledge and improving patient care. Affiliated with Capital Medical University, the hospital specializes in neurology and rehabilitation, providing a robust framework for innovative clinical trials. With a multidisciplinary team of experienced researchers and healthcare professionals, Xuanwu Hospital focuses on conducting high-quality, ethically sound studies that aim to explore new treatment modalities and enhance therapeutic outcomes. Through its dedication to research excellence and patient-centered approaches, Xuanwu Hospital plays a pivotal role in the advancement of healthcare solutions both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Shibao Lu, MD
Study Chair
Xuanwu Hospital of Capital Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported