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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012084
Receipt No. 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

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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
Email 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
Email yasuaoki35@yahoo.co.jp

Sponsor
Institute Department of Orthopaedic Surgery,Toho University Sakura Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011952

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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