UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040230 |
|---|---|
| Receipt number | R000045894 |
| Scientific Title | Comparing outcomes of nonoperative treatment with and without antibiotics for adhesive small bowel obstruction: a nationwide inpatient data study in Japan |
| Date of disclosure of the study information | 2020/04/24 |
| Last modified on | 2020/04/24 10:46:48 |
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Basic information
Public title
Comparing outcomes of nonoperative treatment with and without antibiotics for adhesive small bowel obstruction: a nationwide inpatient data study in Japan
Acronym
Comparing outcomes of nonoperative treatment with and without antibiotics for adhesive small bowel obstruction: a nationwide inpatient data study in Japan
Scientific Title
Comparing outcomes of nonoperative treatment with and without antibiotics for adhesive small bowel obstruction: a nationwide inpatient data study in Japan
Scientific Title:Acronym
Comparing outcomes of nonoperative treatment with and without antibiotics for adhesive small bowel obstruction: a nationwide inpatient data study in Japan
Region
| Japan |
Condition
Condition
Small bowel obstruction
Classification by specialty
| Gastroenterology | Infectious disease | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the benefits of administrating antibiotics in nonoperative treatment for adhesive small bowel obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
in-hospital mortality and the occurrence of sepsis and septic shock
Key secondary outcomes
Clostridioides difficile colitis (A047), length of hospital stay, and total hospitalization costs
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Using a Japanese national inpatient database, we identified SBO patientswho received nasogastric decompression within 2 days after admission from July 2010 to March 2017.
Key exclusion criteria
We excluded patients with: non-adhesive SBO, infectious disease at admission requiring antibiotic administration, and severe conditions requiring intensive care.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Konishi |
Organization
The University of Tokyo
Division name
Department of Breast and Endocrine Surgery, Graduate School of Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-1887
takaakonishi-ncd@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Konishi |
Organization
The University of Tokyo
Division name
Department of Breast and Endocrine Surgery, Graduate School of Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-1887
Homepage URL
takaakonishi-ncd@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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
| 2020 | Year | 04 | Month | 24 | 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
114786
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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This nationwide retrospective cohort study was performed using the Diagnosis Procedure Combination database, which includes hospital administrative claims data and discharge abstracts of approximately 7,000,000 inpatients in more than 1000 hospitals throughout Japan, covering approximately half of all inpatient admissions to acute-care hospitals in Japan. All 82 university hospitals are obliged to participate in the database; participation by community hospitals is voluntary.
Management information
Registered date
| 2020 | Year | 04 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045894
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
