UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005297
Receipt number R000006295
Scientific Title The study of assessment for gastrointestinal motility function using radiopaque marker
Date of disclosure of the study information 2011/04/01
Last modified on 2018/04/04 09:57:38

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Basic information

Public title

The study of assessment for gastrointestinal motility function using radiopaque marker

Acronym

The study of assessment for gastrointestinal motility function using radiopaque marker

Scientific Title

The study of assessment for gastrointestinal motility function using radiopaque marker

Scientific Title:Acronym

The study of assessment for gastrointestinal motility function using radiopaque marker

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the recovery of postoperative gastrointestinal motility function by using radiopaque marker.

Basic objectives2

Others

Basic objectives -Others

It has been suggested that mechanical bowel preparation (MBP) is of no benefit in terms of anastomotic healing, infection rate, or improvement in postoperative course in patients undergoing elective colorectal surgery, indicating that MBP should be abandoned. However, the effect of MBP on postoperative gastrointestinal motility has been assessed subjectively. In this randomized trial, we assessed objectively the effect of MBP on postoperative gastrointestinal motility and mobility in elective colonic resection.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Transition and excretion rate of the radiopaque marker

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Preoprative mechanical bowel preparation

Interventions/Control_2

No preoperative mechanical preparation

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

This study included patients who underwent an elective open or laparoscope-assisted colonic resection (LAC) in our institute. All patients were invited to participate in this trial, which compared outcomes after surgery with or without preoperative MBP. General inclusion criteria were patients with (1) a primary tumor located from the cecum to the sigmoid colon and (2) an American Society of Anesthesiologists grade of I or II.

Key exclusion criteria

Exclusion criteria were a stoma, a complete intestinal obstruction that needed decompression, and a past history of another colonic resection.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Uchida

Organization

Nippon Medical School

Division name

Department of surgery

Zip code


Address

Sendagi 1-1-5 Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

uchida@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Yamada

Organization

Nippon Medical School

Division name

Department of surgery

Zip code


Address

Sendagi 1-1-5 Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

y-tak@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School Department of surgery

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2011 Year 04 Month 01 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

Open public recruiting

Date of protocol fixation

2011 Year 03 Month 20 Day

Date of IRB


Anticipated trial start date

2011 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

2011 Year 03 Month 23 Day

Last modified on

2018 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006295


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name