UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012553 |
|---|---|
| Receipt number | R000014689 |
| Scientific Title | A double-blind, placebo controlled, randomized trial to evaluate the efficacy of Abound (nutrition product including HMB, arginine, and glutamine) on the incidence of wound complications in patients with open surgery. |
| Date of disclosure of the study information | 2013/12/12 |
| Last modified on | 2016/01/11 16:05:26 |
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Basic information
Public title
A double-blind, placebo controlled, randomized trial to evaluate the efficacy of Abound (nutrition product including HMB, arginine, and glutamine) on the incidence of wound complications in patients with open surgery.
Acronym
A double-blind, placebo controlled, randomized trial of Abound in patients with open surgery.
Scientific Title
A double-blind, placebo controlled, randomized trial to evaluate the efficacy of Abound (nutrition product including HMB, arginine, and glutamine) on the incidence of wound complications in patients with open surgery.
Scientific Title:Acronym
A double-blind, placebo controlled, randomized trial of Abound in patients with open surgery.
Region
| Japan |
Condition
Condition
Gastrointestinal malignant tumor
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Abound (nutrition product including HMB, arginine, and glutamine) on the incidence of wound complications in patients with open surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of wound complications
Key secondary outcomes
The incidence of postoperative complications except wound complications, Postoperative hospital stay, muscle mass (skeletal muscle mass, grip strength), moisture content of the skin.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A: Abound
Interventions/Control_2
B: placebo (orange juice)
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
1) Planning open surgery for gastrointestinal stromal tumors.
2) Aged 20 or older.
3) Adequate organ function.
4) Judgement as being able to take orally preoperatively.
5) An ECOG performance status of 0 or 1.
6) Written informed consent.
Key exclusion criteria
1) Previous abdominal operative scar.
2) Emergency surgery.
3) Uncontrollable diabetes millutus or administration of insulin.
4) Systemic steroids medication.
5) Active bacterial or fungous infection.
6) Other conditions judged as inappropriate for the study by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of astroenterological Surgery
Zip code
Address
2-2 E2, Yamadaoka, Suita, Osaka 565-0781, JAPAN
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukinori Kurokawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of astroenterological Surgery
Zip code
Address
2-2 E2, Yamadaoka, Suita, Osaka 565-0781, JAPAN
TEL
06-6879-3251
Homepage URL
ykurokawa@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
大阪大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 11 | Day |
Last modified on
| 2016 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014689
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| Registered date | File name |
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| Registered date | File name |
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