UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005482 |
|---|---|
| Receipt number | 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 10:39:07 |
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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
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
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
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） 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006502
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
