UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012679 |
|---|---|
| Receipt number | 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 08:20:25 |
* 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
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
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
tmoriya@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014715
