UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049738 |
|---|---|
| Receipt number | R000056647 |
| Scientific Title | Analysis of associated factors with complications of spinal surgery. |
| Date of disclosure of the study information | 2022/12/09 |
| Last modified on | 2023/07/18 17:39:41 |
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Basic information
Public title
Analysis of associated factors with complications of spinal surgery.
Acronym
Analysis of associated factors with complications of spinal surgery.
Scientific Title
Analysis of associated factors with complications of spinal surgery.
Scientific Title:Acronym
Analysis of associated factors with complications of spinal surgery.
Region
| Japan |
Condition
Condition
Spine patients
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to investigate the occurrence of the following postoperative complications after spine surgery in patients undergoing spine surgery at Hirosaki University Hospital, using a perioperative complication prevention protocol and perioperative management prospectively.
Basic objectives2
Others
Basic objectives -Others
We hypothesize that elevated inflammatory substance concentrations associated with surgery and general anesthesia and orexin concentrations, a marker of anesthetic arousal, will be associated with the presence of postoperative complications. We will investigate whether EEG, regional cerebral oxygen saturation, and carotid arteriosclerosis are associated with the development of delirium.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative complication
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients 20 years of age or older at the time consent is obtained for spine surgery cases
Key exclusion criteria
Under 20 years old
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | GENTARO |
| Middle name | |
| Last name | KUMAGAI |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori
TEL
0172-39-5083
gen722@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | GENTARO |
| Middle name | |
| Last name | KUMAGAI |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori
TEL
0172-39-5083
Homepage URL
gen722@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of Medicine
Address
Department of Orthopaedic Surgery
Tel
0172-39-5083
gen722@hirosaki-u.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
| 2022 | Year | 12 | Month | 09 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate on 1, 2 weeks, 1, 3, 6 months, 1, 2, and 3 years after surgery.
Management information
Registered date
| 2022 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056647
