UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046614 |
|---|---|
| Receipt number | R000053178 |
| Scientific Title | Effect of gastrectomy on Helicobacter pylori infection |
| Date of disclosure of the study information | 2022/01/12 |
| Last modified on | 2022/02/08 17:41:53 |
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Basic information
Public title
Effect of gastrectomy on Helicobacter pylori infection
Acronym
Effect of gastrectomy on Helicobacter pylori infection
Scientific Title
Effect of gastrectomy on Helicobacter pylori infection
Scientific Title:Acronym
Effect of gastrectomy on Helicobacter pylori infection
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the presence of Helicobacter pylori in the faeces of patients who are positive for Helicobacter pylori antigen in the faeces prior to gastrectomy by means of a fecal Helicobacter pylori antigen test in the postoperative period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of Helicobacter pylori after gastrectomy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone gastrectomy in our hospital on or after 1 April 2015 are eligible.
Key exclusion criteria
Patients who are unable to give consent for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Fujikuni |
Organization
Onomichi General Hospital
Division name
Department of Surgery
Zip code
722-8508
Address
1-10-23 Hirahara, Onomichi, Hiroshima, Japan
TEL
0848-22-8111
fujikuni2292@gmail.com
Public contact
Name of contact person
| 1st name | Senichiro |
| Middle name | |
| Last name | Yanagawa |
Organization
Onomichi General Hospital
Division name
Department of Surgery
Zip code
722-8508
Address
1-10-23 Hirahara, Onomichi, Hiroshima, Japan
TEL
0848-22-8111
Homepage URL
qqry3v7d@silk.ocn.ne.jp
Sponsor or person
Institute
Onomichi General Hospital
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
Ethics Review Committee, Onomichi General Hospital
Address
1-10-23 Hirahara, Onomichi, Hiroshima, Japan
Tel
0848-22-8111
e.asami@hirokouren.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 12 | 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
100
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
| 2016 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2022 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053178
