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
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
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
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
