UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062704 |
|---|---|
| Receipt number | R000067731 |
| Scientific Title | A Prospective Exploratory Study on the Clinical Significance of Lipid Mediator Measurement in Posterior Spinal Fusion for Pediatric Patients with Scoliosis |
| Date of disclosure of the study information | 2026/08/26 |
| Last modified on | 2026/08/26 21:17:31 |
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Basic information
Public title
The significance of lipid change analysis in scoliosis surgery
Acronym
Analysis of lipid in scoliosis surgery
Scientific Title
A Prospective Exploratory Study on the Clinical Significance of Lipid Mediator Measurement in Posterior Spinal Fusion for Pediatric Patients with Scoliosis
Scientific Title:Acronym
Scoli-LiMe (Scoliosis Lipid Mediators Study)
Region
| Japan |
Condition
Condition
Scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the perioperative dynamics of lipid mediators in posterior spinal fusion for scoliosis, a procedure associated with significant surgical invasiveness and severe postoperative pain. Posterior spinal fusion involves placing pedicle screws into the vertebrae and connecting them with rods to correct spinal curvature. Because of its invasiveness, postoperative pain management is often challenging. By examining temporal changes in lipid mediators during the perioperative period, we seek to identify novel therapeutic targets for inflammation and postoperative pain. Such approaches may reduce complications through improved inflammation control, facilitate earlier mobilization and discharge by alleviating postoperative pain, and ultimately contribute to better patient outcomes.
Basic objectives2
Others
Basic objectives -Others
To evaluate the usefulness of investigating perioperative temporal changes in lipid mediators.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Lipid mediators, phospholipids and fatty acids along with Cytokines.
Key secondary outcomes
Pre- and postoperative laboratory data including CRP, WBC, leukocyte differential count, and platelet count.
Vital signs and body temperature obtained from electronic medical records.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with scoliosis and scheduled to undergo posterior spinal fusion under general anesthesia at the University of Tokyo Hospital
Patients aged 10 years or older and 20 years or younger
Patients who understand the purpose of this study and provide informed consent
Key exclusion criteria
Patients for whom surgical cooperation cannot be obtained
Patients taking NSAIDs or tramadol preoperatively
Patients using prostaglandin preparations or lipid mediator antagonists (e.g., montelukast) preoperatively
Patients undergoing reoperation
Patients requiring chronic respiratory support due to scoliosis curvature
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kanji |
| Middle name | |
| Last name | Uchida |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology and Pain relief center
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo-to
TEL
03-5800-8668
kuchidaanes@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Ishihara |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology and Pain relief center
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo-to
TEL
03-5800-8668
Homepage URL
ishiharat-ane@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Kanji Uchida
Funding Source
Organization
Fugaku Fund for the Promotion of Medical Drug Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Institute for
health security
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Research Ethics Support, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo-to
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2026 | Year | 08 | Month | 26 | 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
15
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067731
