UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012084 |
|---|---|
| Receipt number | R000011952 |
| Scientific Title | Comparison Study of Postoperative Positioning after Surgery for Lumbar Degenerative Disease |
| Date of disclosure of the study information | 2013/10/22 |
| Last modified on | 2014/04/21 18:57:43 |
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Basic information
Public title
Comparison Study of Postoperative Positioning after Surgery for Lumbar Degenerative Disease
Acronym
Study of postoperative positioning after lumbar surgery
Scientific Title
Comparison Study of Postoperative Positioning after Surgery for Lumbar Degenerative Disease
Scientific Title:Acronym
Study of postoperative positioning after lumbar surgery
Region
| Japan |
Condition
Condition
Lumbar degenerative Disease
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine which position (Supine or lateral) is more comfortable for patients after lumbar surgery
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative comfort, pain intensity,
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Patients with lumbar degenerative disease treated by surgery were assigned to receive supine postoperative positions
Interventions/Control_2
Patients with lumbar degenerative disease treated by surgery were assigned to receive lateral postoperative positions
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with lumbar degenerative disease treated by lumbar spinal surgery
Key exclusion criteria
Patients who are not able to maintain postoperative position, and are not able to evaluate postoperative discomfort and pain
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuchika Aoki |
Organization
Toho University Sakura Medical Center
Division name
Orthopaedic Surgery
Zip code
Address
564-1 Shimoshizu, Sakura, Chiba
TEL
043-462-8811
yasuaoki35@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuchika Aoki |
Organization
Toho University Sakura Medical Center
Division name
Ethics Committee
Zip code
Address
564-1 Shimoshizu, Sakura, Chiba, Japan
TEL
043-462-8811
Homepage URL
yasuaoki35@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery,Toho University Sakura Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery,Toho University Sakura Medical Center
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
Address
Tel
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
| 2013 | Year | 10 | Month | 22 | 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
The results of this study showed that lateral position is more comfortable than supine position for patients after lumbar spinal surgery.
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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 21 | Day |
Last modified on
| 2014 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011952
