UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040776 |
|---|---|
| Receipt number | R000046565 |
| Scientific Title | Risk Factors for Surgical site infection After Pancreatectomy and the Associated Pathogens; a Retrospective Case-controlled Study |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/06/15 23:50:43 |
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Basic information
Public title
Risk Factors for Surgical site infection After Pancreatectomy and the Associated Pathogens; a Retrospective Case-controlled Study
Acronym
Pathogens Examination From Drainage Fluid After Pancreatectomy
Scientific Title
Risk Factors for Surgical site infection After Pancreatectomy and the Associated Pathogens; a Retrospective Case-controlled Study
Scientific Title:Acronym
Pathogens Examination From Drainage Fluid After Pancreatectomy
Region
| Japan |
Condition
Condition
Pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the risk factors for postoperative pancreatic fistula, to identify pathogen profiles cultured from postoperative drainage fluids, and to evaluate the predictability of high-risk pathogens for severe complications.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of clinically relevant postoperative pancreatic fistula
Key secondary outcomes
the types and the frequencies of microorganisms as related to the severity of the clinically relevant postoperative pancreatic fistula
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who underwent pancreaticoduodenectomy or distal pancreatectomy
Key exclusion criteria
patients who underwent total pancreatectomy or partial pancreatic resection
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Kitago |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-5363-3802
dragonpegasus@keio.jp
Public contact
Name of contact person
| 1st name | Kodai |
| Middle name | |
| Last name | Abe |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-5363-3802
Homepage URL
abe.kodai@gmail.com
Sponsor or person
Institute
Keio University School of Medicine, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine, Department of Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, An Ethics Committee
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
Tel
+81-3-5363-3611
med-rinri-jimu@adst.keio.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 | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
429
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
| 2019 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 10 | 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
Retrospective case-controlled study
Management information
Registered date
| 2020 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046565
