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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000046614
Receipt No. 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

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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
Email 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
Email qqry3v7d@silk.ocn.ne.jp

Sponsor
Institute Onomichi General Hospital
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 Ethics Review Committee, Onomichi General Hospital
Address 1-10-23 Hirahara, Onomichi, Hiroshima, Japan
Tel 0848-22-8111
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053178

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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