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Recruitment status Completed
Unique ID issued by UMIN UMIN000003153
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Showa University School of Medicine Department of Gastroenterological & General Surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003825

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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