UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056346 |
|---|---|
| Receipt number | R000064379 |
| Scientific Title | Perioperative Effects of Preoperative Nutritional Support for Elderly Spine Surgery Patients |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/12/05 14:23:18 |
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Basic information
Public title
Effectiveness of Nutritional Support for Elderly Spine Surgery Patients
Acronym
Effectiveness of Nutritional Support for Elderly Spine Surgery Patients
Scientific Title
Perioperative Effects of Preoperative Nutritional Support for Elderly Spine Surgery Patients
Scientific Title:Acronym
Perioperative Effects of Preoperative Nutritional Support for Elderly Spine Surgery Patients
Region
| Japan |
Condition
Condition
Spine surgery over 75 years old
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the impact of nutritional intervention on clinical outcomes such as postoperative complication rate, length of hospital stay, and functional recovery in a retrospective manner by comparing perioperative nutritional status assessment and active nutritional intervention in a control group of spinal surgery patients over 75 years old who have undergone previous spinal surgery at our hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the incidence of postoperative complications (wound infection, nerve palsy, pneumonia, urinary tract infection, delirium, thrombosis, etc.) in the nutrition intervention and control groups.
Compare changes in pre- and post-operative nutritional assessment (GNRI, CONUT, PNI, NLR) in the nutrition intervention and control groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Nutritional supplements (160 kcal/vial) twice daily from 7-10 days prior to the date of surgery until the day before the date of surgery.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo spine surgery at our hospital
Patients who are 75 years of age or older at the time of scheduled surgery
Patients who have given written consent to participate in the study or who have obtained consent from an appropriate surrogate
Key exclusion criteria
Diabetes mellitus patients with HbA1c level of 8.0% or higher
Chronic kidney disease patients with eGFR less than 15mL/min/1.73m2
Patients with milk or soy allergy
Patients with no residual function of the intestinal tract
Patients with congenital amino acid metabolic disorder
Patients with severe cognitive dysfunction
Patients with emergency hospitalization or emergency surgery
Patients who wish to withdraw their consent by opting out.
Patients who wish to withdraw their consent by opting out.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Onuma |
Organization
Institute of Science Tokyo
Division name
Orthopaedic surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
onuma.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Onuma |
Organization
Institute of Science Tokyo
Division name
Orthopaedic surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
Homepage URL
onuma.orth@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064379
