UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004014 |
|---|---|
| Receipt number | R000004823 |
| Scientific Title | Clinical trial on efficacy of subcutaneous drain in pancreatic surgery |
| Date of disclosure of the study information | 2010/08/07 |
| Last modified on | 2011/08/25 09:48:02 |
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Basic information
Public title
Clinical trial on efficacy of subcutaneous drain in pancreatic surgery
Acronym
Clinical trial on efficacy of subcutaneous drain in pancreatic surgery
Scientific Title
Clinical trial on efficacy of subcutaneous drain in pancreatic surgery
Scientific Title:Acronym
Clinical trial on efficacy of subcutaneous drain in pancreatic surgery
Region
| Japan |
Condition
Condition
pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of surgical site infection for subcutaneous drain after pancreatic operation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of surgical site infection.
Key secondary outcomes
Incidence of wound complication and patient's satisfaction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Subcuticular suture and subcutaneous drain
Interventions/Control_2
Subcuticular suture
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.2500/mm3<WBC<12000/mm3
2.Hb>8.0g/dl
3.Plt>10,0000/mm3
4.Cr<1.5mg/dl
5.Patients from whom informed consent was obtained.
Key exclusion criteria
1.Re-operation
2.Emargency operation
3.clinically significant infectious disease
4.Doctor's decision not to register to this regimen.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Kato |
Organization
Tokai university
Division name
Department of Gastrointestinal Surgery
Zip code
Address
143 simokasuya, Iseharasi, Kanagawa, Japan.
TEL
0463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Kato |
Organization
Tokai university
Division name
Department of Gastrointestinal Surgery
Zip code
Address
143 simokasuya, Iseharasi, Kanagawa, Japan.
TEL
0463-93-1121
Homepage URL
katoken@tokai-u.jp
Sponsor or person
Institute
Tokai University, Department of Gastrointestinal Surgery
Institute
Department
Personal name
Funding Source
Organization
none
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
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
東海大学病院 （神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 07 | Day |
Last modified on
| 2011 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004823
