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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004735
Receipt No. R000005642
Scientific Title A randomized study of early oral nutrition after colorectal surgery in the elderly patients with colorectal cancer
Date of disclosure of the study information 2011/01/04
Last modified on 2010/12/16

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Basic information
Public title A randomized study of early oral nutrition after colorectal surgery in the elderly patients with colorectal cancer
Acronym A randomized study of early oral nutrition in the elderly colorectal cancer patients
Scientific Title A randomized study of early oral nutrition after colorectal surgery in the elderly patients with colorectal cancer
Scientific Title:Acronym A randomized study of early oral nutrition in the elderly colorectal cancer patients
Region
Japan

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

Objectives
Narrative objectives1 investigation of the impact of early oral nutrition after colorectal surgery in the elderly patients with colorectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 30-day complication rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are 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 the group of early oral nutrition after colorectal surgery
Interventions/Control_2 control group
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients older than 75 years of age who were undergoing open or laparoscopic colorectal resection with primary anastomosis
Key exclusion criteria emergency cases and immobile patients
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuminori Teraishi
Organization Kochi Health Sciences Center
Division name Division of Gastroenterological Surgery
Zip code
Address 2125-1 Ike, Kochi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kochi Health Sciences Center
Division name Division of Gastroenterological Surgery
Zip code
Address
TEL 088-837-3000
Homepage URL
Email

Sponsor
Institute Kochi Health Sciences Center
Institute
Department

Funding Source
Organization None
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
2011 Year 01 Month 04 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
2010 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 16 Day
Last modified on
2010 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005642

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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