UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003538 |
|---|---|
| Receipt number | R000004297 |
| Scientific Title | The change of SSI ratio after Pancreatoduodenectomy according to a method of rskin closure. |
| Date of disclosure of the study information | 2010/04/27 |
| Last modified on | 2016/04/26 12:59:53 |
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Basic information
Public title
The change of SSI ratio after Pancreatoduodenectomy according to a method of rskin closure.
Acronym
The ratio of SSI after PD
Scientific Title
The change of SSI ratio after Pancreatoduodenectomy according to a method of rskin closure.
Scientific Title:Acronym
The ratio of SSI after PD
Region
| Japan |
Condition
Condition
patients with PD
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The change of SSi ratio after PD according to a method of skin closeure, damabond vs nylon stich
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
rato of SSI
Key secondary outcomes
hospital stay
Economic effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
damabond method
Interventions/Control_2
nylon stich methods
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
pancreas duct dilatation: yes or no
DM yes or no
age 65 yrs </= or >
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Kubota |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
Address
880 kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2158
kkubota@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsugi Shimoda |
Organization
Second Department of Surgery
Division name
Second Department of Surgery
Zip code
Address
880 Kita kobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2158
Homepage URL
shimodamitsugi@hotmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Dokkyo Medical University
Name of secondary funder(s)
none
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
獨協医科大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
http://www.dokkyomed.ac.jp/dep-m/surg2/index.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.dokkyomed.ac.jp/dep-m/surg2/index.html
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
| 2009 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2016 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004297
