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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019721
Receipt No. 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

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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
Email 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
Email n-fujimura@st-mary-med.or.jp

Sponsor
Institute St. Mary's Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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