UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049955 |
|---|---|
| Receipt number | R000056890 |
| Scientific Title | The effect of intraoral bacterial flora on postoperative complications after upper gastrointestinal surgery |
| Date of disclosure of the study information | 2023/01/02 |
| Last modified on | 2023/07/04 14:24:34 |
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Basic information
Public title
The effect of intraoral bacterial flora on postoperative complications after upper gastrointestinal surgery
Acronym
The effect of intraoral bacterial flora on postoperative complications after upper gastrointestinal surgery
Scientific Title
The effect of intraoral bacterial flora on postoperative complications after upper gastrointestinal surgery
Scientific Title:Acronym
The effect of intraoral bacterial flora on postoperative complications after upper gastrointestinal surgery
Region
| Japan |
Condition
Condition
esophageal tumor, gastric tumor, esophagogastric junction tumor, morbid obesity
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of intraoral bacterial flora on postoperative complications after upper gastrointestinal surgery
Basic objectives2
Others
Basic objectives -Others
To clarify the effect of intraoral bacterial flora on postoperative complications after upper gastrointestinal surgery
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences of the intraoral bacterial flora between the patients with and without postoperative complications
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with malignant or benign tumor, or morbid obesity, who undergo upper gastrointestinal surgery with anastomosis or gastrointestinal suturing
Key exclusion criteria
The patients who undergo upper gastrointestinal surgery without anastomosis or gastrointestinal suturing
The patients who actually do not undergo upper gastrointestinal surgery
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Otake |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Setatsukinowa-cho, Otsu, Shiga
TEL
077-548-2238
rohtake01@gmail.com
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Otake |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Setatsukinowa-cho, Otsu, Shiga
TEL
077-548-2238
Homepage URL
hqsurge1@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Setatsukinowa-cho, Otsu, Shiga
Tel
077-548-3536
hqrec@belle.shiga-med.ac.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
| 2023 | Year | 01 | Month | 02 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
Intraoral specimens of the eligible patients are collected with a non-invasive procedure in routine perioperative care. Intraoral specimens and local site specimens are collected when postoperative complications occur.
Intraoral bacterial flora of each patient is identified by analyzing the specimens.
Postoperative course of each patient is observed in a process of routine medical treatment.
Effects of intraoral bacterial flora on postoperative complications after upper gastrointestinal surgery are analyzed.
Management information
Registered date
| 2023 | Year | 01 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056890
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
