UMIN-CTR Clinical Trial

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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