UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052696 |
|---|---|
| Receipt number | R000060133 |
| Scientific Title | The study of the improvement of postoperative gastrointestinal motility by taste stimulation |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/04 17:23:41 |
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Basic information
Public title
The study of the improvement of postoperative gastrointestinal motility by taste stimulation
Acronym
The study of the improvement of postoperative gastrointestinal motility by taste stimulation
Scientific Title
The study of the improvement of postoperative gastrointestinal motility by taste stimulation
Scientific Title:Acronym
The study of the improvement of postoperative gastrointestinal motility by taste stimulation
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the improvement of postoperative gastrointestinal motility by taste stimulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of postoperative ileus
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Group taking tablets after surgery
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
18 years of age or older who have undergone laparoscopic colorectal resection at our hospital
Key exclusion criteria
Those who lack the capacity to give consent
Those who have undergone reoperation for recurrence of colorectal cancer
Those with stoma
Those with inflammatory bowel disease as the primary disease
Those who are judged by the principal investigator or subinvestigators to be inappropriate to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Norikatsu |
| Middle name | |
| Last name | Miyoshi |
Organization
Osaka university, Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
E2, 2-2, Yamadaoka, Suita-shi, Osaka
TEL
06-6879-3251
nmiyoshi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Norikatsu |
| Middle name | |
| Last name | Miyoshi |
Organization
Osaka university, Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
E2, 2-2, Yamadaoka, Suita-shi, Osaka
TEL
06-6879-3251
Homepage URL
nmiyoshi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
UHA Mikakuto
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka university Hospital Ethics Review Committee
Address
2-2, Yamadaoka, Suita-shi, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | 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
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060133
