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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | The study to promote perioperative bowel movement.
-The effect of chewing gum- |
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Acronym | The study to promote perioperative bowel movement.
-The effect of chewing gum- |
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Scientific Title | The study to promote perioperative bowel movement.
-The effect of chewing gum- |
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Scientific Title:Acronym | The study to promote perioperative bowel movement.
-The effect of chewing gum- |
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Region |
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Condition | ||
Condition | Inflammatory bowel disease | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | without asignment.
patients with Diabetes mellitus. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |