UMIN-CTR Clinical Trial

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