UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003439 |
|---|---|
| Receipt number | R000004166 |
| Scientific Title | Perioperative synbiotic treatment to prevent postoperative infectious complications after laparoscopic colorectal surgery |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2015/05/21 18:57:37 |
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Basic information
Public title
Perioperative synbiotic treatment to prevent postoperative infectious complications after laparoscopic colorectal surgery
Acronym
Perioperative synbiotic treatment in laparoscopic colorectal surgery
Scientific Title
Perioperative synbiotic treatment to prevent postoperative infectious complications after laparoscopic colorectal surgery
Scientific Title:Acronym
Perioperative synbiotic treatment in laparoscopic colorectal surgery
Region
| Japan |
Condition
Condition
Elective laparoscopic colorectal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess whether infectious complications after laparoscopic surgery can be suppressed by the pre and postoperative administration of synbiotics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Occurrence of postoperative infectious complications
Key secondary outcomes
Plasma level of CRP after surgery
Intestinal microflora attached to the epithelium of the resected specimen
Intestinal microflora, pH, and organic acids in the feces or mucus
Changes in the immune functions of the resected intestine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily administration of synbiotics both for more than 7 days before surgery and from 2 to 7 postoperaive days
Interventions/Control_2
Control (without placebo)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo elective laparoscopic colorectal surgery in Nagoya Daini Red Cross Hospital
Key exclusion criteria
In case significant changes are needed in the planning of surgery (e.g. addition of hepatectomy or urinary tract diversion).
Those who prefer to drink beverages of synbiotics or those who dislike such products.
Those who have difficulty in taking water because of the diseases, such as bowel obstruction.
Those who cannot understand the concept of the study (e.g. dementia or mental disorders).
Patients who do not have enough time to take synbiotics products for more than 7 days before surgery (e.g. when the surgery should be scheduled as soon as possible after the admission.)
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichiro Komatsu |
Organization
Nagoya Daini Red Cross Hospital
Division name
Surgery
Zip code
Address
2-9, Myokencho, Showaku, Nagoya City, Aichi Pref.
TEL
052-832-1121
skomat@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunichiro Komatsu |
Organization
Nagoya Daini Red Cross Hospital
Division name
Surgery
Zip code
Address
2-9, Myokencho, Showaku, Nagoya City, Aichi Pref.
TEL
052-832-1121
Homepage URL
skomat@nagoya2.jrc.or.jp
Sponsor or person
Institute
Nagoya Daini Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute for Microbiological Research
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yakult Central Institute for Microbiological Research
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
名古屋第二赤十字病院(愛知県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s00595-015-1178-3
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
| 2008 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 06 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 02 | Day |
Last modified on
| 2015 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004166
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
