UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002753 |
|---|---|
| Receipt number | 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 | 2020/08/09 13:39:51 |
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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 | Alan |
| Middle name | Kawarai |
| Last name | Lefor |
Organization
Jichi Medical University
Division name
Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
81+285587371
alefor@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Yokota |
Organization
Jichi Medical University
Division name
Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
81+285587371
Homepage URL
froyokota@hotmail.com
Sponsor or person
Institute
Department of Surgery, Jichi Medical University
Institute
Department
Personal name
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
Jichi Medical University
Address
3311-1Yakushiji Shimotsuke
Tel
0285-44-2100
rinri@jichi.ac.jp
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
PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032
Publication of results
Published
Result
URL related to results and publications
PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032
Number of participants that the trial has enrolled
676
Results
PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032
Results date posted
| 2020 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032
Participant flow
PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032
Adverse events
None
Outcome measures
PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 20 | Day |
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
Yokota S, Koizumi M, Togashi K, et al. Preoperative pulmonary function tests do not predict the development of pulmonary complications after elective major abdominal surgery: A prospective cohort study. Int J Surg. 2020;73:65-71. doi:10.1016/j.ijsu.2019.11.032
Management information
Registered date
| 2009 | Year | 11 | Month | 11 | Day |
Last modified on
| 2020 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003321
