UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025623 |
|---|---|
| Receipt number | R000029478 |
| Scientific Title | Usefulness of synbiotics before hepatic resection |
| Date of disclosure of the study information | 2017/01/11 |
| Last modified on | 2018/07/14 11:49:07 |
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Basic information
Public title
Usefulness of synbiotics before hepatic resection
Acronym
Usefulness of synbiotics before hepatic resection
Scientific Title
Usefulness of synbiotics before hepatic resection
Scientific Title:Acronym
Usefulness of synbiotics before hepatic resection
Region
| Japan |
Condition
Condition
liver
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to compare the group that performs synbiotics before hepatectomy and the historical group that does not perform synbiotics and examine the effect of synbiotics for SSI after hepatectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between preoperative synbiotics and SSI in patients with hepatectomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Butyric acid bacteria + water soluble dietary fiber
Interventions/Control_2
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) Patients diagnosed as liver tumors (benign, malignant).
2) Patients who are judged to have liver resection by laparotomy or laparoscopy.
3). Patient who is below Performance Status (PS) 1 and is independent in daily life.
4) Patients aged 20 years or older at the time of acquiring consent.
5) Patients who had consent from the patients themselves by free will after explanation to participate in this study.
Key exclusion criteria
1) Patients who administered lactic acid bacteria or butyric acid bacteria preparations within one month before the study
2) Patients undergoing artificial dialysis due to severe renal impairment
3) Patients who require dietary restrictions such as inflammatory bowel disease
4) Patients with preoperative PS of 2 or more.
Target sample size
176
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroya Iida |
Organization
Shiga University of Medical Science
Division name
Surgery
Zip code
Address
Seta Tsukinowa-cho
TEL
077-548-2238
hiroya@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya Iida |
Organization
Shiga University of Medical Science
Division name
Surgery
Zip code
Address
Seta Tsukinowa-cho
TEL
077-548-2238
Homepage URL
hiroya@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 01 | Month | 11 | 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
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | 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
| 2017 | Year | 01 | Month | 11 | Day |
Last modified on
| 2018 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029478
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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