UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017399 |
|---|---|
| Receipt number | R000016535 |
| Scientific Title | The prognosis of intraoperative nutrition in major abdominal surgery |
| Date of disclosure of the study information | 2015/05/02 |
| Last modified on | 2023/10/25 21:14:10 |
* 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
The prognosis of intraoperative nutrition in major abdominal surgery
Acronym
The prognosis of intraoperative nutrition
Scientific Title
The prognosis of intraoperative nutrition in major abdominal surgery
Scientific Title:Acronym
The prognosis of intraoperative nutrition
Region
| Japan |
Condition
Condition
major abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Anesthesiology |
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study were the prognosis of intraoperative nutrition in major abdominal surgery and to determine nitrogen balance during operation with and without the administration of amino acids, and whether glucose and amino acids are consumed to supply energy during operation. We determine the resting energy expenditure (REE) of patients during surgery under general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The objectives of this study were the prognosis of intraoperative nutrition in major
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravenous fluid with glucose and amino acids
Interventions/Control_2
intravenous fluid without glucose and amino acids
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
major abdominal surgery over 6 hours
Key exclusion criteria
major abdominal surgery under 6 hours
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Juntendo University School of Medicine
Division name
department of anesthesiology and pain medicine
Zip code
113-8421
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
ds0226@fsinet.or.jp
Public contact
Name of contact person
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Juntendo University School of Medicine
Division name
department of anesthesiology and pain medicine
Zip code
113-8421
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ds0226@fsinet.or.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
department of anesthesiology and pain medicine
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
Ethics Committee of Juntendo University Hospital.
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
juntencrc@juntendo.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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
UMIN000017399
Publication of results
Unpublished
Result
URL related to results and publications
UMIN000017399
Number of participants that the trial has enrolled
40
Results
The lengths of hospital stay were similar between the GA and C groups. However, ketone body levels were significantly higher in the C group than in the GA group at T2. Additionally, nitrogen balance in the GA group was significantly higher than that in the C group during anesthesia.
Results date posted
| 2022 | Year | 07 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
laparoscopic colorectal cancer surgery.
Participant flow
written informed consent was obtained from the participants on the day before surgery.
Adverse events
None
Outcome measures
we measured patients length of hospital stay and took measurements before and after surgery, including during general anesthesia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016535
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/02/16 | 研究計画書（修正）新201８.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/05/06 | 研究計画書（修正）新2017.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/05/06 | 研究計画書（修正）新2017.docx |
