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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012679
Receipt No. R000014715
Scientific Title Effects of preoperative use of an immune-enhancing diet on postoperative complications and long-term outcome: a randomized clinical trial in colorectal cancer surgery for Japanese patients
Date of disclosure of the study information 2014/01/01
Last modified on 2013/12/25

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Basic information
Public title Effects of preoperative use of an immune-enhancing diet on postoperative complications and long-term outcome: a randomized clinical trial in colorectal cancer surgery for Japanese patients
Acronym Effects of preoperative use of an immune-enhancing diet on surgical outcome
Scientific Title Effects of preoperative use of an immune-enhancing diet on postoperative complications and long-term outcome: a randomized clinical trial in colorectal cancer surgery for Japanese patients
Scientific Title:Acronym Effects of preoperative use of an immune-enhancing diet on surgical outcome
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of preoperative Immune Enhancing Diets on postoperative complications in Japanese patients who underwent curative colorectal cancer surgery.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the rate of infectious complication

Key secondary outcomes Length of post operative stay
the rate of non-infectious complication
Length of SIRS day
mortality rate
Overall survival rate
Disease free survival rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 IMPACT 600ml
Interventions/Control_2 IMPACT 200ml
Interventions/Control_3 Control
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 Patients who will undergo colorectal surgery.
Key exclusion criteria Patients who cannot tolerate enteral nutrition, who have severe heart, respiratory, renal and liver dysfunction
and who are severe malnutrition.

Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Hase
Organization National Defense Medical College Hospital
Division name Department of Surgery, National Defense Medical College
Zip code
Address 3-2, Namiki, Tokorozawa, Japan
TEL 04-2995-1211
Email kazuh@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Moriya
Organization National Defense Medical College Hospital
Division name Department of Surgery
Zip code
Address 3-2, Namiki, Tokorozawa, Japan
TEL 04-2995-1211
Homepage URL
Email tmoriya@ndmc.ac.jp

Sponsor
Institute National Defense Medical College Hospital
Institute
Department

Funding Source
Organization National Defense Medical College
Organization
Division
Category of Funding Organization
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
2014 Year 01 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 Completed
Date of protocol fixation
2002 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2002 Year 12 Month 01 Day
Last follow-up date
2011 Year 12 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
2013 Year 12 Month 25 Day
Last modified on
2013 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014715

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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