UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036761 |
|---|---|
| Receipt number | R000041889 |
| Scientific Title | Analysis of relationship between surgical outcome and preoperative nutrition for patients with digestive malignancy |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2019/05/15 22:14:04 |
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Basic information
Public title
Analysis of relationship between surgical outcome and preoperative nutrition for patients with digestive malignancy
Acronym
Relationship between surgical outcome and preoperative nutrition
Scientific Title
Analysis of relationship between surgical outcome and preoperative nutrition for patients with digestive malignancy
Scientific Title:Acronym
Relationship between surgical outcome and preoperative nutrition
Region
| Japan |
Condition
Condition
malignant tumor of digestive organs
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the relationship between nutritional state and postoperative complecations
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of peri-operative complications
Key secondary outcomes
Mortality rate
The incidence of reoperation during 30 days after surgery
The incidence of readmission during 30 days after surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Malignant tumor of digestive organs
2) Surgical resection was performed
3) Enrolled in National Clinical Database
Key exclusion criteria
1) Non-epithelial tumor
2) Surgical resection for recurrent or metastatic tumor
Target sample size
400000
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Takeuchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL
053-435-2279
takeuchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hiramatsu |
Organization
Hamamatsu University School of Medicine
Division name
Department of Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL
053-435-2279
Homepage URL
hiramatsu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Gastroenterological Surgery
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 of Hamamatsu University School of Medicine (EC HUSM)
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
Tel
053-435-2680
rinri@hama-med.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
| 2019 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database analysis
Management information
Registered date
| 2019 | Year | 05 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041889
