UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013667 |
|---|---|
| Receipt number | R000015950 |
| Scientific Title | Preoperative nutrition and exercise program to prevent the complications after pancreaticoduodenectomy |
| Date of disclosure of the study information | 2014/04/14 |
| Last modified on | 2020/04/15 20:49:59 |
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Basic information
Public title
Preoperative nutrition and exercise program to prevent the complications after pancreaticoduodenectomy
Acronym
Preoperative nutrition and exercise program to prevent the complications after pancreaticoduodenectomy
Scientific Title
Preoperative nutrition and exercise program to prevent the complications after pancreaticoduodenectomy
Scientific Title:Acronym
Preoperative nutrition and exercise program to prevent the complications after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Pancreatectomy patient
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of preoperative exercise and diet program to prevent the postoperative complications after pancreas surgery.
Basic objectives2
Others
Basic objectives -Others
a
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of complications after pancreas surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Diet therapy
Therapeutic exercise
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient who perfoms Pancreatectomy
2. The patient who obtained its consent by informed consent
Key exclusion criteria
1, The patient who cannot do body movement
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Adachi |
Organization
Nagasaki university
Division name
Department of surgery
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7316
adatomo@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Adachi |
Organization
Nagasaki university
Division name
Department of surgery
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7316
Homepage URL
adatomo@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university
Department of 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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 04 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 08 | Day |
Last modified on
| 2020 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015950
