UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021875 |
|---|---|
| Receipt number | 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 09:44:36 |
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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
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
mstshnd@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025219
