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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025407
Receipt No. R000029249
Scientific Title Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older
Date of disclosure of the study information 2017/01/01
Last modified on 2018/06/15

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Basic information
Public title Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older
Acronym Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older
Scientific Title Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older
Scientific Title:Acronym Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older
Region
Japan

Condition
Condition spine disease
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess the perioperative complication rates and risk factors of spine surgery in patients aged 80 years or older
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes perioperative complications and mortality within 30 days postoperatively
Key secondary outcomes reoperation within 30 days

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 spine surgery
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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients aged 80 years or older who undergo spine surgery for degenerative spine diseases
Key exclusion criteria patients with pyogenic spondylitis, metastatic bone tumor, spinal trauma or spinal cord injury
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamasa Watanabe
Organization Hakodate Central General Hospital
Division name Spine center
Zip code
Address 33-2, Honcho, Hakodate city, Hokkaido
TEL 0138-52-1231
Email watanabe-t@hakochu-hp.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamasa Watanabe
Organization Hakodate Central General Hospital
Division name Spine center
Zip code
Address 33-2, Honcho, Hakodate city, Hokkaido
TEL 0138-52-1231
Homepage URL
Email watanabe-t@hakochu-hp.gr.jp

Sponsor
Institute Hokkaido Spine Study Group
Institute
Department

Funding Source
Organization Hokkaido Spine Study Group
Organization
Division
Category of Funding Organization Non profit foundation
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 函館中央病院(北海道)、北海道大学病院(北海道)、北海道せき損センター(北海道)、北海道整形外科記念病院(北海道)、えにわ病院(北海道)、市立札幌病院(北海道)、斗南病院(北海道)、釧路ろうさい病院(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 01 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 Completed
Date of protocol fixation
2016 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 26 Day
Last modified on
2018 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029249

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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