UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039562 |
|---|---|
| Receipt number | R000045116 |
| Scientific Title | "Effects of improving preoperative nutritional status on postoperative complications -Prospective study in spinal deformity surgery- " |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2020/02/21 20:26:05 |
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Basic information
Public title
"Effects of improving preoperative nutritional status on postoperative complications
-Prospective study in spinal deformity surgery- "
Acronym
"Effects of improving preoperative nutritional status on postoperative complications"
Scientific Title
"Effects of improving preoperative nutritional status on postoperative complications
-Prospective study in spinal deformity surgery- "
Scientific Title:Acronym
"Effects of improving preoperative nutritional status on postoperative complications"
Region
| Japan |
Condition
Condition
The spinal deformity case with malnutritional status
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether preoperative nutritional guidance and intervention can reduce the incidence of complications in spinal deformity surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medical complications during hospitalization (delirium; diagnosis by confusion assessment method, pneumonia, urinary tract infection, etc.)
Key secondary outcomes
Examination of effects of nutritional status on X-ray alignment.
Examination of the effect of nutritional status on health-related quality of life.
To determine whether nutrition intervention can increase PNI before surgery.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Ingestion of dietary supplements for about 1-3 months from the time of spinal surgery decision
Interventions/Control_2
To provide nutritional guidance every month from the time of spinal deformity decision
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Fixation of more than 5 vertebrae has been performed or will be performed.
2. To meet any of X-ray parameters as belows; PT> 20 degree, TK> 60 degree, or SVA> 50mm
3. A subject who has given the written consent of the subject (in the case of a minor, the subject and his or her delegate) (The subject of the historical cotontrol study is difficult to obtain consent and it will be applied with opt-out)
4. A person who has given consent by written consent to use the patient background data or image data for research
Key exclusion criteria
1. Patients with neuromuscular diseases such as Parkinson's disease
2. Patients with syndromic scoliosis
3. Patients undergoing surgery for spinal deformity due to infection or tumor
4. Patient judged to be inappropriate by the attending physician
5. Those who did not obtain consent to participate in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Oe |
Organization
Hamamatsu University School of medicine
Division name
Geriatric musculoskeletal Health
Zip code
4313192
Address
Handayama 1-20-1, Higashi ward, Hamamatsu city, Shizuoka, Japan
TEL
0534352299
mecersior@gmail.com
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Oe |
Organization
Hamamatsu University School of medicine
Division name
Geriatric musculoskeletal health
Zip code
4313192
Address
Handayama 1-20-1, Higashi ward, Hamamatsu city, Shizuoka, Japan
TEL
0534352299
Homepage URL
mecersior@gmail.com
Sponsor or person
Institute
Hamamatsu University School of medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of medicine
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
Hamamatsu University School of medicine
Address
Handayama 1-20-1, Higashi ward, Hamamatsu city, Shizuoka, Japan
Tel
0534352299
mecersior@gmail.com
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
浜松医科大学病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 21 | 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
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 21 | Day |
Last modified on
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045116
