UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038497 |
|---|---|
| Receipt number | R000043834 |
| Scientific Title | Investigation of postoperative nutritional management for dialysis patients undergoing digestive surgery and the association between the timing of starting oral intake after surgery and the outcome: A cohort study using DPC database |
| Date of disclosure of the study information | 2019/12/05 |
| Last modified on | 2020/04/14 16:50:24 |
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Basic information
Public title
Investigation of postoperative nutritional management for dialysis patients undergoing digestive surgery and the association between the timing of starting oral intake after surgery and the outcome: A cohort study using DPC database
Acronym
The postoperative nutritional management for dialysis patients undergoing digestive surgery
Scientific Title
Investigation of postoperative nutritional management for dialysis patients undergoing digestive surgery and the association between the timing of starting oral intake after surgery and the outcome: A cohort study using DPC database
Scientific Title:Acronym
The postoperative nutritional management for dialysis patients undergoing digestive surgery
Region
| Japan |
Condition
Condition
Dialysis patients who underwent digestive resection
Classification by specialty
| Nephrology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In dialysis patients who underwent digestive resection,
(1) to clarify the clinical practice of postoperative nutrition management
(2) to investigate the association between the timing of starting oral intake after surgery and the outcome
Basic objectives2
Others
Basic objectives -Others
Survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative complications within 30 days after surgery
(anastomotic leakage, surgical site infection, pneumonia, urinary tract infection, catheter infection )
Key secondary outcomes
- Mortality in a hospital
- Mortality within 30 days after surgery
- Worsening of ADL at discharge
- Rehospitalization within 30 days after discharge
- Length of postoperative hospital stay
- 15-day postoperative hospital stay - Controlling nutritional status at discharge
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients aged 18 years or older who underwent any of the following digestive resection surgeries from January 1, 2009 to December 31,2018
1) Esophageal surgery
2) Stomach surgery
3) Biliary and gallbladder surgery
4) Liver surgery
5) Pancreatic surgery
6) Small intestine surgery
7) Colon surgery
8) Rectal surgery
(2) Patients who have records of dialysis conducted one week before surgery and within 30 days after surgery
Key exclusion criteria
(1) Patients who have no body weight data
(2) Patients whose height is less than 100cm or 200cm or more
(3) Patients whose body weight is less than 10kg or 200kg or more
(4) Patients who died within 7 days after surgery
(5) Patients who were discharged within 7 days after surgery
(6) Patients who underwent emergency surgery
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Iijima |
Organization
Osaka Prefectural Hospital Organization
Osaka International Cancer Institute
Division name
Nutritional Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka city, Osaka
TEL
06-6945-1181
Shohei.iijima@oici.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Tani |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Applied Clinical Development Department
Zip code
101-0048
Address
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
TEL
03-5217-5954
Homepage URL
Tani.Miyuki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Factory, Inc.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Prefectural Hospital Organization
Osaka International Cancer Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka city, Osaka
Tel
06-6945-1181
rinri01@opho.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 | 12 | Month | 05 | 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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 16 | Day |
Other
Other related information
Study design
A cohort study using the medical database
Data source
A medical database provided by Medical Data Vision Co. Ltd.
The database is based on the DPC data/medical and technical service claims data. The database covers about 20% of all DPC hospitals in Japan. All data is anonymized from the viewpoint of personal information protection.
Management information
Registered date
| 2019 | Year | 11 | Month | 05 | Day |
Last modified on
| 2020 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043834
| Research Plan | |
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| Registered date | File name |
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| Research case data | |
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