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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021875
Receipt No. R000025219
Scientific Title The risk of preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.
Date of disclosure of the study information 2016/05/01
Last modified on 2018/02/11

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Basic information
Public title The risk of preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.
Acronym The factors influencing of postoperative course undergoing thoracic and abdominal surgery.
Scientific Title The risk of preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.
Scientific Title:Acronym The factors influencing of postoperative course undergoing thoracic and abdominal surgery.
Region
Japan

Condition
Condition Patients undergoing thoracic and abdominal surgery
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is conduct to investigate preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The factor influencing postoperative mobilization examine preoperative physical function.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria were planned surgery and written informed consent.
Key exclusion criteria Exclusion criteria were comorbid conditions affecting exercise performance (e.g. musculoskeletal or neurological impairment) and re-operation.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Email mstshnd@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Homepage URL
Email mstshnd@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
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
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 長崎大学病院(長崎県),製鉄記念八幡病院(福岡県),公立陶性病院(愛知県),長崎みなとメディカルセンター市民病院(長崎県),JCHO北海道病院(北海道),聖隷三方原病院(静岡県),KKR高松病院(香川県)

Other administrative information
Date of disclosure of the study information
2016 Year 05 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
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design
prospective observational study

Inclusion criteria
We enrolled in patients underwent cardiac surgery group and thoracic surgery group, abdominal surgery group.

Statistical analyses
Variables of preoperative physical function, age, gender, body mass index, operative time and blood loss

Management information
Registered date
2016 Year 04 Month 11 Day
Last modified on
2018 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025219

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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