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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007534
Receipt No. R000008896
Scientific Title Effects of perioperative administration of carbohydrate and amino acids on Intraoperative vital signs and postoperative recovery after hepatectomy.
Date of disclosure of the study information 2012/03/20
Last modified on 2016/03/19

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Basic information
Public title Effects of perioperative administration of carbohydrate and amino acids on Intraoperative vital signs and postoperative recovery after hepatectomy.
Acronym Effects of perioperative administration of carbohydrate and amino acids
Scientific Title Effects of perioperative administration of carbohydrate and amino acids on Intraoperative vital signs and postoperative recovery after hepatectomy.
Scientific Title:Acronym Effects of perioperative administration of carbohydrate and amino acids
Region
Japan

Condition
Condition Patients who are scheduled to undergo hepatectomy.
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of perioperative administration of carbohydrate and amino acids on intraoperative vital signs and postoperative recovery in patients who are going to undergo hepatectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraoperative vital signs (body temperature, blood pressure, etc.)
Postoperative complications including hepatic failure, bile leakage, and hemorrhage.
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Preoperative intake of hepan (carbohydrate and amino acids rich enteral nutrition)+Intraoperative amino acid infusion
Interventions/Control_2 Prohibit preoperative oral intake within 24 hours. Intraoperative lactoringer infusion
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are going to undergo hepatectomy.
Key exclusion criteria 1. Patients who did not agree with the participation.
2. Patients with a history of chmo- and/or radio-therapy.
3. Patients with a history of hepatectomy.
4. Patients with severe complications.
5. Patients with severe diabetes.
6. Patients who need continuous administration of steroid.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nagino Masato
Organization Nagoya University Graduate School of Medicine
Division name Department of Surgery, Division of Surgical Oncology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-2222
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yokoyama Yukihiro
Organization Nagoya University Graduate School of Medicine
Division name Department of Surgery, Division of Surgical Oncology
Zip code
Address
TEL
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization N.A.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 03 Month 20 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
2012 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 19 Day
Date of closure to data entry
2016 Year 03 Month 19 Day
Date trial data considered complete
2016 Year 03 Month 19 Day
Date analysis concluded
2016 Year 03 Month 19 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 19 Day
Last modified on
2016 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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