UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019721 |
|---|---|
| Receipt number | R000022774 |
| Scientific Title | A comparison of epidural versus general anesthesia for incidence of mesenteric traction syndrome during gynecologic surgery |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2015/11/26 12:01:30 |
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Basic information
Public title
A comparison of epidural versus general anesthesia for incidence of mesenteric traction syndrome during gynecologic surgery
Acronym
Mesenteric traction syndrome during gynecologic surgery
Scientific Title
A comparison of epidural versus general anesthesia for incidence of mesenteric traction syndrome during gynecologic surgery
Scientific Title:Acronym
Mesenteric traction syndrome during gynecologic surgery
Region
| Japan |
Condition
Condition
gynecologic surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare epidural versus general anesthesia with remifentanil for incidence of mesentric traction syndrome during gynecologic surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of mesentric traction syndrome during surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
epidural anesthesia
Interventions/Control_2
general anesthesia with remifentanil
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
gynecologic surgery
Key exclusion criteria
anticoagulant treatment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Fujimura |
Organization
St. Mary's Hospital
Division name
Anesthesilogy
Zip code
Address
Tsubukuhonnmachi, Kurume, Fukuoka
TEL
0942-35-3322
n-fujimura@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyuki Fujimura |
Organization
St. Mary's Hospital
Division name
Anesthesilogy
Zip code
Address
Tsubukuhonnmachi, Kurume, Fukuoka
TEL
0942-35-3322
Homepage URL
n-fujimura@st-mary-med.or.jp
Sponsor or person
Institute
St. Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Mary's Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 10 | 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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2015 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022774
