UMIN-CTR Clinical Trial

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	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group of patients undergoing gastrectomy followed by Helicobacter pylori eradication will be tested after one year.
Interventions/Control_2	The group of patients who do not undergo Helicobacter pylori eradication after gastrectomy will be tested after one year.
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 01 Month 12 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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