UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051028 |
|---|---|
| Receipt number | R000058176 |
| Scientific Title | Preoperative prognostic predictors and treatment strategies for surgical treatment of non-obstructive intestinal ischemia |
| Date of disclosure of the study information | 2023/05/10 |
| Last modified on | 2023/05/10 14:12:40 |
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Basic information
Public title
Preoperative prognostic predictors and treatment strategies for surgical treatment of non-obstructive intestinal ischemia
Acronym
Preoperative prognostic predictors and treatment strategies for surgical treatment of non-obstructive intestinal ischemia
Scientific Title
Preoperative prognostic predictors and treatment strategies for surgical treatment of non-obstructive intestinal ischemia
Scientific Title:Acronym
Preoperative prognostic predictors and treatment strategies for surgical treatment of non-obstructive intestinal ischemia
Region
| Japan |
Condition
Condition
non-obstructive intestinal ischemia
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate risk factors for in-hospital mortality among patients with NOMI who underwent laparotomy and to examine therapeutic strategies that could improve the prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
alive until 30 days of postoperative duration
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
we reviewed the electronic medical records of patients from January 2011 to January 2021; these records were retrieved from the inpatient databases of eight hospitals. NOMI was diagnosed based on contrast-enhanced CT findings, operative and autopsy findings, and presence of pathological ischemic lesions without thrombi in the mesenteric blood vessels.
Key exclusion criteria
patients with ischemic changes in the inferior mesenteric artery region were excluded to distinguish them from those with ischemic colitis.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Murata |
Organization
Shonan Kamakura General Hospital
Division name
General Surgery
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura, Kanagawa 247-8533, Japan
TEL
0467461717
ukenukenuken@gmail.com
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Murata |
Organization
Shonan Kamakura General Hospital
Division name
General Surgery
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura, Kanagawa 247-8533, Japan
TEL
0467461717
Homepage URL
ukenukenuken@gmail.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Shonan Kamakura General Hospital
Address
1370-1 Okamoto, Kamakura, Kanagawa 247-8533, Japan
Tel
0467461717
ukenukenuken@gmail.com
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 | 05 | Month | 10 | 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
88
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058176
