UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049138 |
|---|---|
| Receipt number | R000055973 |
| Scientific Title | Usefulness of new liquid enteral nutrition formula in perioperative patients in the field of gastrointestinal surgery. |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/01/10 17:50:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Usefulness of new liquid enteral nutrition formula in perioperative patients in the field of gastrointestinal surgery.
Acronym
Usefulness of new liquid enteral nutrition formula in perioperative patients.
Scientific Title
Usefulness of new liquid enteral nutrition formula in perioperative patients in the field of gastrointestinal surgery.
Scientific Title:Acronym
Usefulness of new liquid enteral nutrition formula in perioperative patients.
Region
| Japan |
Condition
Condition
Digestive disease
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients scheduled for gastrointestinal surgery (upper gastrointestinal tract, lower gastrointestinal tract, liver, biliary, pancreas), the new liquid enteral nutrition formula was administered as dietary therapy before and after surgery. The purpose of this study is to examine the usefulness of the new liquid enteral nutrition formula by comparing the incidence of infectious diseases, the rate of improvement in nutritional status, and other parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative infections.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Normal hospital meal is taken from 2 days before surgery until 7 days after reaching the postoperative maintenance dose.
Interventions/Control_2
A new liquid enteral nutrition formula is taken from 2 days before surgery until 7 days after reaching the postoperative maintenance dose.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled for surgical operation (upper gastrointestinal tract, lower gastrointestinal tract, liver, biliary, pancreas).
2. Patients who can take oral nutrition.
3. Patients aged >=20 and <75.
4. Subjects who explained this research using a written informed consent document and obtained informed consent.
Key exclusion criteria
1. Weight loss =>10% (compared to normal weight over the last 6 months).
2. Patients with swallowing dysfunction.
3. Patients with liver dysfunction (Child-Pugh class C).
4. Patients with respiratory dysfunction (arterial blood PaO2<70 torr).
5. Patients with renal impairment (plasma creatinine level >2 mg/dL).
6. Patients with cardiac dysfunction (New York classification>3).
7. Patients who are pregnant.
8. Patients with infectious diseases.
9. Immunocompromised patients.
10. Patients judged to require total parenteral nutrition.
11. Patients who become calorie restricted after hospitalization due to comorbidities, or who may become calorie restricted.
12. Patients judged inappropriate for participation in this research by the principal investigator or co-investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshida |
Organization
Nippon Medical School Hospital
Division name
Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
s-shinji@nms.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Shinji |
Organization
Nippon Medical School Hospital
Division name
Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
s-shinji@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
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
Central Ethics Committee of the Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
chuorinri.group@nms.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
| 2022 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055973
