UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040046 |
|---|---|
| Receipt number | R000045657 |
| Scientific Title | Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2020/04/03 16:43:30 |
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Basic information
Public title
Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery
Acronym
Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery
Scientific Title
Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery
Scientific Title:Acronym
Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery
Region
| Japan |
Condition
Condition
Patients underwent digestive and general surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors for postoperative complications
Basic objectives2
Others
Basic objectives -Others
To examine the impact of postoperative ambulation on short-term outcome
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence/Absence of Postoperative complications
Key secondary outcomes
Hospitalization
Discharge destination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent major digestive surgery (surgical procedures with resection of the gastrointestinal tract, liver, biliary tract, or pancreas)
Key exclusion criteria
1) patients were under 19 years old
2) patients underwent emergency surgery
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
Faculty of Medicine, Academic Assembly
University of Toyama
Division name
Department of Surgery and Science
Zip code
930-0194
Address
2630, Sugitani, Toyama
TEL
+81-76-434-7331
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Baba |
Organization
Faculty of Medicine, Academic Assembly University of Toyama
Division name
Department of Surgery and Science
Zip code
930-0194
Address
2630, Sugitani, Toyama
TEL
+81-76-434-7331
Homepage URL
h881088@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
Ethics Committee, University of Toyama
Address
2630, Sugitani, Toyama
Tel
+81-76-415-8857
rinri@adm.u-toyama.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 31 | 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
Suspended
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study
Management information
Registered date
| 2020 | Year | 04 | Month | 03 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045657
