An interventional study of Oral nutritional supplements (ONS) and Carbohydrate loading (OCL) in Lumbar Degenerative Disease, Lumbar Spondylolisthesis and Lumbar Disc Herniation, sponsored by First Affiliated Hospital of Kunming Medical University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by First Affiliated Hospital of Kunming Medical University · Not applicable, Interventional, and Supportive care
Patients undergoing open posterior lumbar fusion surgery often experience postoperative gastrointestinal problems, such as bloating, constipation, and delayed passage of gas and stool, and may be at nutritional risk. These problems may hinder recovery and prolong hospital stay.
This study enrolled 90 patients undergoing open posterior lumbar fusion surgery at the Department of Orthopedics, First Affiliated Hospital of Kunming Medical University. Participants were randomly assigned in a 1:1:1 ratio to three groups: a control group receiving routine perioperative care with standard dietary guidance; experimental group A receiving perioperative oral nutritional supplements (ONS) together with preoperative and postoperative carbohydrate loading; and experimental group B receiving the same ONS and carbohydrate loading plus a probiotic preparation.
The primary outcome was the length of postoperative hospital stay. Other assessments included time to first postoperative flatus, time to first postoperative bowel movement, cumulative postoperative drainage volume, drainage duration, and time to first postoperative mobilization out of bed. Surgical wound healing, postoperative infections, and overall postoperative complications were assessed during hospitalization and at the outpatient follow-up visit 1 month after surgery. Additional assessments included anthropometric measurements, laboratory tests, and scores evaluating pain, function, nutritional risk, nutritional status, dietary intake, and gastrointestinal function.
Anthropometric measurements were obtained at hospital admission and at the pre-discharge assessment. The Visual Analog Scale (VAS) for overall pain, Japanese Orthopaedic Association (JOA) low back pain score, Nutritional Risk Screening 2002 (NRS-2002), full Mini Nutritional Assessment (MNA), Simple Diet Self-Assessment Tool (SDSAT), and simplified gastrointestinal function score were assessed at hospital admission, on postoperative day 3, at the pre-discharge assessment, and at 1 month after surgery. Laboratory tests were performed before surgery and on postoperative days 1, 3, and 6.
The aim was to evaluate the clinical value of perioperative nutrition management in spinal surgery and explore whether adding probiotics provided further benefit. The study was intended to inform the development of a practical perioperative nutrition management plan to support recovery, shorten hospital stay, and reduce postoperative complications.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 143 interventional studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →First Affiliated Hospital of Kunming Medical University is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Immunosuppression
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Routine perioperative care with standard dietary guidance. Patients receive routine dietary counseling after a nutrition consultation, conventional preoperative fasting (no food or drink for more than 8 hours), and a gradual diet transition from liquids to regular food after passage of gas. No oral nutritional supplements or probiotics are provided.
Optimized perioperative oral nutritional supplements (ONS) plus preoperative and postoperative carbohydrate loading. ONS is given from 2 days before surgery to 5 days after surgery, with an energy target of about 30 kcal/kg/day and protein intake of 1.5-2.0 g/kg/day.
Dietary Supplement: Oral nutritional supplements (ONS) · Dietary Supplement: Carbohydrate loading (OCL)
ONS plus carbohydrate loading (identical to group A) plus a probiotic preparation. Bifidobacterium and Lactobacillus triple live capsules (2 g orally three times daily) are added from 2 days before surgery to 5 days after surgery.
Dietary Supplement: Oral nutritional supplements (ONS) · Dietary Supplement: Carbohydrate loading (OCL) · Biological: 'Probiotics (Bifidobacterium and Lactobacillus triple live capsules)'
Perioperative optimized oral nutritional supplements (whole-nutrient formula plus whey protein; diabetes-specific formula for patients with diabetes), taken as between-meal snacks from 2 days before surgery to 5 days after surgery, to reach an energy target of about 30 kcal/kg/day and protein intake of 1.5-2.0 g/kg/day.
Preoperative and postoperative oral carbohydrate loading. A 12.5% carbohydrate drink is given as 400 ml at 10 hours and 200 ml at 2 hours before surgery, and 200 ml after waking from anesthesia, followed by a liquid and semi-liquid diet as tolerated.
Bifidobacterium and Lactobacillus triple live capsules (a live microbial preparation), 2 g orally three times daily, from 2 days before surgery to 5 days after surgery.
Length of postoperative hospital stay
Number of days from surgery to hospital discharge during the index hospitalization.
Time frame: From surgery to hospital discharge during the index hospitalization, up to 17 days after surgery.
Time to first postoperative flatus
Time from the end of surgery to the first passage of flatus, measured in hours.
Time frame: From returning to the ward after surgery until the first passage of flatus, up to 29 hours after surgery.
Time to first postoperative bowel movement
Time from the end of surgery to the first bowel movement, measured in hours.
Time frame: From returning to the ward after surgery until the first bowel movement, up to 126 hours after surgery.
Total postoperative drainage volume
Cumulative postoperative drainage volume collected until drain removal, measured in milliliters.
Time frame: After surgery until drain removal, up to postoperative day 7.
Postoperative drainage duration
Duration from postoperative day 1 to drain removal, measured in days.
Time frame: From postoperative day 1 until drain removal, up to postoperative day 7.
Time to first postoperative out-of-bed mobilization
Timing of the first postoperative mobilization out of bed after the end of surgery, recorded as the postoperative day number. Postoperative day 1 is the calendar day after surgery.
Time frame: From the end of surgery until the first mobilization out of bed, up to postoperative day 8.
Percentage of participants with impaired surgical wound healing
Percentage of participants with impaired healing of the surgical incision, based on clinical observation during the index hospitalization and reassessment at the outpatient follow-up visit 1 month after surgery. Each participant with impaired wound healing is counted once.
Time frame: During the index postoperative hospitalization (up to 17 days after surgery) and at 1 month after surgery.
Percentage of participants with postoperative infections
Percentage of participants who experienced at least one postoperative infection by 1 month after surgery. Infections include surgical incision infections, pulmonary infections (including pneumonia), urinary tract infections, and deep tissue infections. Events are ascertained during hospitalization and at the 1-month outpatient follow-up visit. Each participant is counted once, regardless of the number or sites of infection.
Time frame: During the index postoperative hospitalization (up to 17 days after surgery) and at the outpatient follow-up visit 1 month after surgery.
Percentage of participants with postoperative complications
Percentage of participants who experienced at least one postoperative complication by 1 month after surgery. Complications include postoperative infections, gastrointestinal reactions (abdominal distension, constipation, or diarrhea), impaired surgical wound healing, lower-limb deep vein thrombosis, renal insufficiency, and pressure ulcers. Events are ascertained during hospitalization and at the 1-month outpatient follow-up visit. Each participant is counted once, regardless of the number or types of complication.
Time frame: During the index postoperative hospitalization (up to 17 days after surgery) and at the outpatient follow-up visit 1 month after surgery.
Body mass index
Body mass index calculated as body weight in kilograms divided by height in meters squared, reported in kg/m\^2.
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Triceps skinfold thickness
Triceps skinfold thickness, measured in millimeters.
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mid-upper arm circumference
Mid-upper arm circumference, measured in centimeters.
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mid-upper arm muscle circumference
Mid-upper arm muscle circumference, reported in centimeters.
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Mean bilateral handgrip strength
Arithmetic mean of the left- and right-hand grip strength measurements, reported in kilograms.
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Waist circumference
Waist circumference, measured in centimeters.
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Hip circumference
Hip circumference, measured in centimeters.
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Waist-to-hip ratio
Waist circumference divided by hip circumference, with both measurements expressed in centimeters. The ratio is dimensionless.
Time frame: At hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).
Visual Analog Scale score for overall pain
Overall pain intensity assessed using a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity.
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Japanese Orthopaedic Association low back pain score
Low back symptoms and function assessed using the Japanese Orthopaedic Association (JOA) low back pain score. The score includes subjective symptoms (0 to 9 points), clinical signs (0 to 6 points), activities of daily living (0 to 14 points), and urinary bladder function (-6 to 0 points). The total score ranges from -6 to 29 points, with higher scores indicating better clinical status and function.
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Nutritional Risk Screening 2002 score
Nutritional risk assessed using Nutritional Risk Screening 2002 (NRS-2002). The total score is the sum of the impaired nutritional status score (0 to 3) and the disease severity score (0 to 3), with 1 additional point for participants aged 70 years or older. The total score ranges from 0 to 7, with higher scores indicating greater nutritional risk.
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Mini Nutritional Assessment total score
Nutritional status assessed using the full 18-item Mini Nutritional Assessment (MNA). The screening section (0 to 14 points) and assessment section (0 to 16 points) are summed to obtain a total score ranging from 0 to 30. Higher scores indicate better nutritional status.
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Simple Diet Self-Assessment Tool score
Dietary intake assessed using the five-level Simple Diet Self-Assessment Tool (SDSAT) shown in the study assessment form. Scores range from 1 to 5. Higher scores indicate greater estimated dietary energy and protein intake.
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Simplified gastrointestinal function score
Gastrointestinal dysfunction assessed in three domains: abdominal distension or pain, nausea or vomiting, and diarrhea. Each domain is scored from 0 to 5. The overall score is the highest of the three domain scores and ranges from 0 (normal gastrointestinal function) to 5 (severe impairment). Higher scores indicate worse gastrointestinal dysfunction.
Time frame: At hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
White blood cell count
White blood cell count, reported in 10\^9/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
C-reactive protein
C-reactive protein concentration, reported in mg/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Erythrocyte sedimentation rate
Erythrocyte sedimentation rate, reported in mm/h.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Serum albumin
Serum albumin concentration, reported in g/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Total lymphocyte count
Total lymphocyte count, reported in 10\^9/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Hemoglobin
Hemoglobin concentration, reported in g/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Total cholesterol
Total cholesterol concentration, reported in mmol/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol (LDL-C) concentration, reported in mmol/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
High-density lipoprotein cholesterol
High-density lipoprotein cholesterol (HDL-C) concentration, reported in mmol/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Triglycerides
Triglyceride concentration, reported in mmol/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Prealbumin
Prealbumin concentration, reported in mg/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Transferrin
Transferrin concentration, reported in g/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Retinol-binding protein
Retinol-binding protein concentration, reported in mg/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
Creatinine
Creatinine concentration, reported in micromol/L.
Time frame: Before surgery and on postoperative days 1, 3, and 6.
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Plan to share: No — Individual participant data will not be shared with other researchers.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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First Affiliated Hospital of Kunming Medical University