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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005482
Receipt No. R000006502
Scientific Title Study of the best epidural catheter location in ERAS protocol as perioperative medical care in rectum/sigmoid colon surgery
Date of disclosure of the study information 2011/04/22
Last modified on 2013/02/11

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Basic information
Public title Study of the best epidural catheter location in ERAS protocol as perioperative medical care in rectum/sigmoid colon surgery
Acronym Study of the best epidural catheter location in ERAS protocol
Scientific Title Study of the best epidural catheter location in ERAS protocol as perioperative medical care in rectum/sigmoid colon surgery
Scientific Title:Acronym Study of the best epidural catheter location in ERAS protocol
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the best epidural catheter location for postoperative analgesia and gastrointestinal recovery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes effect of postoperative analgesia and gastrointestinal recovery
Key secondary outcomes postoperative lengths of stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Place the epidural catheter in the lower-thoracic level
Interventions/Control_2 Place the epidural catheter in the mid-thoracic level
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 Patients who reseive rectum/sigmoid colon surgery and epidural catheter were inserted as perioperative medical care
Key exclusion criteria Patients whose epidural analgesia were canceled within 2 days
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko TAGAWA
Organization Tokyo Metropolitan Bokutoh hospital
Division name Dept. Anesthesiology
Zip code
Address 4-23-5 Koto-bashi, Sumida-ku, Tokyo
TEL 03-3633-6151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kyoko TAGAWA
Organization Tokyo Metropolitan Bokutoh hospital
Division name Dept. Anesthesiology
Zip code
Address 4-23-5 Koto-bashi, Sumida-ku, Tokyo
TEL 03-3633-6151
Homepage URL
Email

Sponsor
Institute Tokyo Metropolitan Bokutoh hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 東京都立墨東病院(東京都)     Tokyo Metropolitan Bokutoh hospital

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 22 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
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
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 21 Day
Last modified on
2013 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006502

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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