UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053645 |
|---|---|
| Receipt number | R000061121 |
| Scientific Title | A survey of nutritional management after gastrointestinal cancer surgery and an association between the parenteral nutritional prescriptions and clinical outcomes: a cohort study using a medical database |
| Date of disclosure of the study information | 2024/02/19 |
| Last modified on | 2024/11/27 16:02:03 |
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Basic information
Public title
A survey of nutritional management after gastrointestinal cancer surgery and an association between the parenteral nutritional prescriptions and clinical outcomes: a cohort study using a medical database
Acronym
Nutritional management after surgery and clinical outcomes for gastrointestinal cancer patients
Scientific Title
A survey of nutritional management after gastrointestinal cancer surgery and an association between the parenteral nutritional prescriptions and clinical outcomes: a cohort study using a medical database
Scientific Title:Acronym
Nutritional management after surgery and clinical outcomes for gastrointestinal cancer patients
Region
| Japan |
Condition
Condition
Patients operated for gastrointestinal cancer surgery under general anesthesia
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify nutritional management in early postoperative period for gastrointestinal cancer patients and to investigate the association between the parenteral nutritional prescription doses and clinical outcomes for patients who are fasting over 7 days after surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative events
Key secondary outcomes
In-hospital mortality
Postoperative complication
Activities of daily living
Readmission
Length of stay
Medical costs
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 operated for gastrointestinal cancer surgery under general anesthesia between January 1, 2011 and December 31, 2022
2. Patients aged 18 years or older
Key exclusion criteria
1. Patients whose height or body weight data is missing
2. Patients whose height is less than 100 cm or 200 cm or more
3. Patients whose body weight is less than 10 kg or 200 kg or more
4. Patients who died or were discharged within 7 days after surgery
5. Patients who received oral feeding or enteral nutrition within 7 days after surgery
6. Patients whose doses of parenteral energy was less than 5 kcal/kg/day or 30 kcal/kg/day or more on average from 1 to 7 days after surgery
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Kamoshita |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Medical Affairs Department Research and Development Center
Zip code
101-0048
Address
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo, Japan
TEL
03-5217-5954
kamoshitas@otsuka.jp
Public contact
Name of contact person
| 1st name | Nahoki |
| Middle name | |
| Last name | Hayashi |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Medical Affairs Department Research and Development Center
Zip code
101-0048
Address
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo, Japan
TEL
03-5217-5954
Homepage URL
Hayashi.Nahoki@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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2024 | Year | 02 | Month | 19 | 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
18294
Results
From 2011 to 2022, more patients received early oral intake, and fewer patients were received early parenteral nutrition (PN). Energy and amino acid doses prescribed in PN were deficient, and almost no lipid was prescribed. The associations between clinical adverse events and parenteral energy/amino acid doses were investigated. Parenteral energy doses were not associated with clinical adverse events, but amino acid doses were significantly associated with clinical adverse events.
Results date posted
| 2024 | Year | 11 | Month | 27 | Day |
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
| 2024 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
A cohort study using the medical claims 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 27% of all DPC hospitals in Japan. All data is anonymized from the viewpoint of personal information protection.
1. Survey of nutritional management
The nutritional management is surveyed based on the prescription and treatment records available in the database. We analyze the following items.
･Route of nutritional administration
･Situation of nutritional management
･Risk factors for long-term fasting
･Prescribed dose of parenteral nutrition
･Percentage achieving nutritional recommendations by BMI
2. Association between the nutritional prescription doses and clinical outcomes
Patients who are fasting over 7 days after surgery are divided into some groups based on the nutritional prescribed doses. The Association between the nutritional prescription doses and clinical outcomes are investigated by multivariable logistic regression analysis used to estimate odds ratios and the 95% confidence intervals adjusted for patient backgrounds as confounding factors.
Management information
Registered date
| 2024 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061121
