UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019112 |
|---|---|
| Receipt number | R000022094 |
| Scientific Title | Randamized control trial for the effect of preoperative carbohydrate loading on the post operative hyperglycemia and evaluatioin of time to eliminate gastric contents on the patients with colorectal cancer surgery |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/09/25 10:15:45 |
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Basic information
Public title
Randamized control trial for the effect of preoperative carbohydrate loading on the post operative hyperglycemia and evaluatioin of time to eliminate gastric contents on the patients with colorectal cancer surgery
Acronym
The effect of preoperative carbohydrate loading on the postsurgical hyperglycemia
Scientific Title
Randamized control trial for the effect of preoperative carbohydrate loading on the post operative hyperglycemia and evaluatioin of time to eliminate gastric contents on the patients with colorectal cancer surgery
Scientific Title:Acronym
The effect of preoperative carbohydrate loading on the postsurgical hyperglycemia
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the effect of preoperative carbohydrate loading on the post operative hyperglycemia and evaluation of time to eliminate gastric contents on the patients with colorectal cancer surgery among control, 12.5% carbohydrate loading group and 17.5% carbohydrate loading group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Improvement of insulin resistance pre- and post- operation with HOMA-R
Blood glucose
Concentration of blood insulin
Key secondary outcomes
Time to first stool from operation
Time to eat 'Gobugayu'.Gobugayu is Japanese Rice porridge cooked with water 10 % rice.
Days to discharge hospital.
Rates of reoperation
Rates of readmission
Postoperative mortality
Rate of postoperative complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The control group: At preoperative night, patient drinks 800mL of water. From 2.5 to 3 hours before operation, patients drink 400mL of water.
Interventions/Control_2
The 12.5% of carbohydrate group: At preoperative night, patient drinks 800mL of 12.5% of carbohydrate. Before 2.5 to 3 hours to operation, patients drink 400mL of 12.5% of carbohydrate.
Interventions/Control_3
The 16.7% of carbohydrate group: At preoperative night, patient drinks 600mL of 16.7% of carbohydrate. From 2.5 to 3 hours before operation, patients drink 300mL of 16.7% of carbohydrate.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who require the colorectal cancer surgery and are able to eat orally and aged from 20 to 70.
Obtained written consent to this study.
Key exclusion criteria
1 With comorbidity and classed ASA 3 or over
2 With comorbidity of diabetes mellitus or their HbA1c is 6.5 or over.
3 With their BMI over 30
4 Patients who take steroids or other drugs which have possibility of influence to blood glucose
5 Patients who require steroids or other drugs which have possibility of influence to blood glucose
6 With abnormal gastrointestinal function. For example, pyloric stenosis or past history of gastric resection.
7 With chronic kidney disease.(estimated GFR<60)
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Higashibeppu |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Anesthesia and Critical Care
Zip code
Address
2-1-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
0783024321
gashibe@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Higashibeppu |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Anesthesia and Critical Care
Zip code
Address
2-1-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
0783024321
Homepage URL
gashibe@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
神戸市立医療センター中央市民病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 25 | Day |
Last modified on
| 2015 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022094
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