UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032228 |
|---|---|
| Receipt number | R000036750 |
| Scientific Title | Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis. A multiple institutional prospective study. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2025/10/18 18:52:11 |
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Basic information
Public title
Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis. A multiple institutional prospective study.
Acronym
Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis.
Scientific Title
Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis. A multiple institutional prospective study.
Scientific Title:Acronym
Investigation for the mechanism of bacterial translocation in patients undergoing surgery of intestinal necrosis.
Region
| Japan |
Condition
Condition
Patients who are going to undergo open abdominal surgery for intestinal necrosis.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the mechanism of bacterial translocation using samples from patients undergoing surgery for intestinal necrosis.
Basic objectives2
Others
Basic objectives -Others
To investigate the pattern of bacterial translocation in necrotic intestine.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clarify the mechanism of bacterial translocation in human by examining blood, feces, resected intestinal specimen, and mesenteric lymph nodes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Use the specimens from patients undergoing a surgery for intestinal necrosis. Analyze the resected specimen, mesenteric lymph nodes, blood, and fecal samples.
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
All patients undergoing surgery for intestinal necrosis.
Key exclusion criteria
Not applicable.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
466
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2218
yyoko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2218
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Division of Surgical Oncology, Department of Surgery
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Surgical Oncology, Department of Surgery
Nagoya University Graduate School of Medicine
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
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2973
ethics@med.nagoya-u.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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
not applicable
Publication of results
Unpublished
Result
URL related to results and publications
not applicable
Number of participants that the trial has enrolled
0
Results
The spread of COVID-19 made it difficult to enroll patients, and the trial was canceled.
Results date posted
| 2025 | Year | 10 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
not applicable
Participant flow
not applicable
Adverse events
not applicable
Outcome measures
not applicable
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 13 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036750
