UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003153 |
|---|---|
| Receipt number | R000003825 |
| Scientific Title | The influence of mechanical bowel preparation upon microflora in patients undergoing colon cancer resection -A Randomized Controlled Trial- |
| Date of disclosure of the study information | 2010/02/09 |
| Last modified on | 2010/02/09 01:25:39 |
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Basic information
Public title
The influence of mechanical bowel preparation upon microflora in patients undergoing colon cancer resection -A Randomized Controlled Trial-
Acronym
The influence of mechanical bowel preparation upon microflora in patients undergoing colon cancer resection -A Randomized Controlled Trial-
Scientific Title
The influence of mechanical bowel preparation upon microflora in patients undergoing colon cancer resection -A Randomized Controlled Trial-
Scientific Title:Acronym
The influence of mechanical bowel preparation upon microflora in patients undergoing colon cancer resection -A Randomized Controlled Trial-
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the influence of preoperative mechanical bowel preparation upon microflora in patients undergoing colon cancer resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The main outcome is evaluation of bacterial microflora and fecal organic acid and PH of fecal material before surgery and first fecal material after surgery and intraoperative fecal material if it was collected in resected specimen.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients in the MBP Group are allowed to have a regular diet until noon before surgery and to have water until midnight before surgery. Patients in the MBP group receive with magnesium citrate pharmaceutical isocratic liquid the day before surgery, and were given Grycelin enema on the day of surgery.
Interventions/Control_2
The non-MBP group have no preoperative MBP. Patients in the non-MBP Group are allowed to have a regular diet until two days before surgery and to have liquid diet before surgery.
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
ASA grade I or II
Key exclusion criteria
Intestinal obstruction or perforation
Physical status IV or V on ASA grade
History of colon resection
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Watanabe |
Organization
Showa University School of Medicine
Division name
Department of Gastroenterological & General Surgery
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku Tokyo, 142-8666, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Showa University School of Medicine
Division name
Department of Gastroenterological & General Surgery
Zip code
Address
TEL
03-3784-8541
Homepage URL
Sponsor or person
Institute
Showa University School of Medicine Department of Gastroenterological & General Surgery
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine Department of Gastroenterological & General Surgery
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
| 2010 | Year | 02 | Month | 09 | 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
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2010 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003825
