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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002753
Receipt No. R000003321
Scientific Title Predicting risk of postoperative pulmonary complications with history and physical examination
Date of disclosure of the study information 2009/11/16
Last modified on 2017/11/17

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Basic information
Public title Predicting risk of postoperative pulmonary complications with history and physical examination
Acronym Predicting risk of postoperative pulmonary complications
Scientific Title Predicting risk of postoperative pulmonary complications with history and physical examination
Scientific Title:Acronym Predicting risk of postoperative pulmonary complications
Region
Japan

Condition
Condition Elective abdominal surgery
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate history and physical examination are equally or more predictive of pulmonary complications than pulmonary function tests.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Morbidity of postoperative pulmonary complications
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who undergo elective abdominal surgery under general anesthesia at Jichi Medical University Hospital
Key exclusion criteria None
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Alan K Lefor
Organization Jichi Medical University
Division name Surgery
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 81+285587371
Email alefor@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Yokota
Organization Jichi Medical University
Division name Surgery
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 81+285587371
Homepage URL
Email froyokota@hotmail.com

Sponsor
Institute Department of Surgery, Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 16 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 No longer recruiting
Date of protocol fixation
2009 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information Now on analysis.

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2017 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003321

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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