UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009111 |
|---|---|
| Receipt number | R000007591 |
| Scientific Title | Study of the effect of flurbiprofen for prevention of mesenteric traction syndrome. |
| Date of disclosure of the study information | 2012/10/14 |
| Last modified on | 2017/10/21 19:14:13 |
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Basic information
Public title
Study of the effect of flurbiprofen for prevention of mesenteric traction syndrome.
Acronym
MTS trial
Scientific Title
Study of the effect of flurbiprofen for prevention of mesenteric traction syndrome.
Scientific Title:Acronym
MTS trial
Region
| Japan |
Condition
Condition
mesenteric traction syndrome (colorectal cancer)
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the mesenteric traction syndrome can be prevented by administration of flurbiprofen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of mesenteric traction syndrome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of flurbiprofen axetil during induction of anesthesia
Interventions/Control_2
Administration of flurbiprofen axetil after the onset of mesenteric traction syndrome.
Interventions/Control_3
No preventive action
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elected abdominal colorectal surgery patients in our hospital
Key exclusion criteria
Liver dysfunction
Renal dysfunction
Gastroduodenal ulcer
Aspirin-induced asthma
Laparoscopic surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemasa takahashi |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Dept. anesthesiology
Zip code
Address
4-23-15,Kotobashi,Sumida-ku, Tokyo,130-8575,Japan
TEL
03-3633-6151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidemasa takahashi |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Dept. anesthesiology
Zip code
Address
4-23-15,Kotobashi,Sumida-ku, Tokyo,130-8575,Japan
TEL
03-3633-6151
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Health Chemistry, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京都立墨東病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 14 | Day |
Last modified on
| 2017 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007591
