UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037131
Receipt number R000042319
Scientific Title The study to promote perioperative bowel movement. -The effect of chewing gum-
Date of disclosure of the study information 2019/08/01
Last modified on 2019/06/21 20:17:16

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Basic information

Public title

The study to promote perioperative bowel movement.
-The effect of chewing gum-

Acronym

The study to promote perioperative bowel movement.
-The effect of chewing gum-

Scientific Title

The study to promote perioperative bowel movement.
-The effect of chewing gum-

Scientific Title:Acronym

The study to promote perioperative bowel movement.
-The effect of chewing gum-

Region

Japan


Condition

Condition

Inflammatory bowel disease

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evalute the effect ofchwing gum for promiting perioperative bowel movement, physical symptoms and psycological aspect.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

The day for first defecation after surgery

Key secondary outcomes

niveau on X-ray
ileus


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

chewing gum

Interventions/Control_2

none chewing gum

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

IBD patients between 20years old and 80years old.
IBD patients who understand and signet this study.
IBD petients who observed no signe of aspiration at the time of restant drinking.
independent of activity of daily living.
agreement of doctor.

Key exclusion criteria

without asignment.
patients with Diabetes mellitus.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kumiko
Middle name
Last name Oomura

Organization

Fukuoka university Chikushi Hospital

Division name

Nursing department the eighth floor east ward

Zip code

818-8502

Address

Chikusino city, Fukuoka Prefecture Zokumyoin 1-1-1

TEL

092-921-1011

Email

oomura@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Kumiko
Middle name
Last name Oomura

Organization

Fukuoka university Chikushi Hospital

Division name

Nursing department the eighth floor east ward

Zip code

818-8502

Address

Chikusino city, Fukuoka Prefecture Zokumyoin 1-1-1

TEL

092-921-1011

Homepage URL


Email

oomura@fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka university Chikushi Hospital.
Nursing department the eighth floor east ward.

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

Fukuoka University Chikushi Hospital Clinical Research Support Center

Address

Chikusino city, Fukuoka Prefecture Zokumyoin 1-1-1

Tel

092-921-1011

Email

chikushirinsho@adm.fukuoka-u.ac.jp


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

福岡大学筑紫病院(福岡県)


Other administrative information

Date of disclosure of the study information

2019 Year 08 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

Preinitiation

Date of protocol fixation

2019 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 06 Month 21 Day

Last modified on

2019 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042319


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name