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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038497
Receipt No. 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

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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
Email 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
Email Tani.Miyuki@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Factory, Inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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