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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037131
Receipt No. 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

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

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
URL(English) https://upload.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


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