UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026292
Receipt number R000030199
Scientific Title Daikenchuto for enhancement of bowel movement after open abdominal surgery: a pooled analysis of three randomized controlled trials
Date of disclosure of the study information 2017/02/24
Last modified on 2019/02/26 08:51:09

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Basic information

Public title

Daikenchuto for enhancement of bowel movement after open abdominal surgery: a pooled analysis of three randomized controlled trials

Acronym

Daikenchuto for enhancement of bowel movement after open abdominal surgery: a pooled analysis of three randomized controlled trials

Scientific Title

Daikenchuto for enhancement of bowel movement after open abdominal surgery: a pooled analysis of three randomized controlled trials

Scientific Title:Acronym

Daikenchuto for enhancement of bowel movement after open abdominal surgery: a pooled analysis of three randomized controlled trials

Region

Japan


Condition

Condition

colon cancer/liver cancer/gastric cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to perform a pooled-analysis to determine the role of DKT in accelerating GI recovery after open abdominal surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the time from the end of surgery (tracheal tube extubation) to the first bowel movement.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Data of 862 patients from three clinical trials, JFMC-project number 39-0902, 40-1001 and 42-1002 were pooled.

Key exclusion criteria

122 patients excluded from an analysis.

Target sample size

740


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuo Shimada

Organization

Institute of Biomedical Sciences,Tokushima University Graduate School

Division name

Department of Surgery

Zip code


Address

Kuramoto 3-18-15, Tokushima 770-8503

TEL

088-633-7139

Email

jfmc-dc@jfmc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Division name

Office

Zip code


Address

1-28-6 kameido, koto-ku, Tokyo, 136-0071 Japan

TEL

03-5627-7594

Homepage URL


Email

jfmc-dc@jfmc.or.jp


Sponsor or person

Institute

Japanese Foundation for Multidisciplinary Treatment of Cancer

Institute

Department

Personal name



Funding Source

Organization

TSUMURA & CO.

Organization

Division

Category of Funding Organization

Profit organization

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

2017 Year 02 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s00595-019-01787-9

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

2017 Year 02 Month 16 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

JFMC39-0902(UMIN000001592)
JFMC40-1001(UMIN000003103)
JFMC42-1002(UMIN000004693)


Management information

Registered date

2017 Year 02 Month 24 Day

Last modified on

2019 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030199


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name