![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | Helicobacter pylori infection
|
|
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |