UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032669 |
|---|---|
| Receipt number | R000037252 |
| Scientific Title | Safety Evaluation of drinking on post-gastrectomy patients |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/08/17 14:09:32 |
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Basic information
Public title
Safety Evaluation of drinking on post-gastrectomy patients
Acronym
Safety Evaluation of drinking on post-gastrectomy patients
Scientific Title
Safety Evaluation of drinking on post-gastrectomy patients
Scientific Title:Acronym
Safety Evaluation of drinking on post-gastrectomy patients
Region
| Japan |
Condition
Condition
post-gastrectomy patients
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety Evaluation of drinking on post-gastrectomy patients
Basic objectives2
Others
Basic objectives -Others
Investigation of drinking on postgastrectomy
patient
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Absorption and decomposition rate of alcohol
Key secondary outcomes
Adverse event (Nausea, vomiting, indisposition, headaches, fatigue) incidence up to 24 hours after drinking alcohol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
post-gastrectomy patients
Interventions/Control_2
Healthy person
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Outpatient of our hospital
2. Patients who underwent po st-gastrectomy(with lymphadenectomy) for gastric cancer
3. Patients who have not recurred for more than 1 year after surgery
4. Patients who had taken habitual alcohol intake before surgery
5. Patients who received written consent for participation in the study
Key exclusion criteria
1. Alcohol hypersensitivity patients
2. History of liver function disorder
3. History of alcohol abuse
4. Taking any anti-neoplastic agent
5. Under treatment for other malignant disease
6. Taking any drugs designed as contraindication with alcohol intake
7. No drinking habit before surgery
8. Less than 20 years old
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Michitaka |
| Middle name | |
| Last name | Honda |
Organization
Fukushima Medical University
Division name
Department of Minimally Invasive Surgical and Medical Oncology
Zip code
960-1247
Address
Hikarigaoka 1, Fukushima-shi, Fukushima
TEL
024-547-1111
mhonda@fukuhsimamed.com
Public contact
Name of contact person
| 1st name | Masatake |
| Middle name | |
| Last name | Tamaki |
Organization
Fukushima Medical University
Division name
Department of Minimally Invasive Surgical and Medical Oncology
Zip code
960-1247
Address
Hikarigaoka 1, Fukushima-Shi, Fukushima
TEL
024-547-1111
Homepage URL
tamaki@japanscr.org
Sponsor or person
Institute
Southern Tohokou General Hospital
Institute
Department
Personal name
Funding Source
Organization
Southern Tohokou General Hospital
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
Sougou Minamitouhoku hospital
Address
Fukushimaken Kooriyama-shi Hachiyamada 7-115
Tel
024-934-5322
kensyu@mt.strins.or.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
総合南東北病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
25
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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | 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
| 2018 | Year | 05 | Month | 22 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037252
