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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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