UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027796 |
|---|---|
| Receipt number | R000031851 |
| Scientific Title | Appropriate timing of removal of epidural and urethral catheters to avoid postoperative urinary retention undergoing abdominal surgery |
| Date of disclosure of the study information | 2017/06/17 |
| Last modified on | 2018/07/22 17:37:21 |
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Basic information
Public title
Appropriate timing of removal of epidural and urethral catheters to avoid postoperative urinary retention undergoing abdominal surgery
Acronym
Appropriate timing of removal of epidural and urethral catheters
Scientific Title
Appropriate timing of removal of epidural and urethral catheters to avoid postoperative urinary retention undergoing abdominal surgery
Scientific Title:Acronym
Appropriate timing of removal of epidural and urethral catheters
Region
| Japan |
Condition
Condition
Patients who underwent epidural anesthesia and major abdominal surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the incidence of postoperative urinary retention (POUR) in patients who received epidural anesthesia and evaluated the appropriate timing of epidural and urethral catheter removal
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of POUR
Key secondary outcomes
Age
Sex
Height
Weight
BMI(body mass index)
Past history of risks for POUR
Use of drugs for voiding dysfunction
Surgical field
Operation procedure
Operation time
Epidural opioid use/amount
The day for removal of epidural catheter
The day of urinary catheter removal
The interval of removal timing between epidural and urinary catheter
The thoracic/lumbar level of epidural catheter
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Between September and December 2014, patients who underwent epidural anesthesia and major abdominal surgery in Wakayama Medical University hospital.
Key exclusion criteria
1) Patients who denied the entry of this study
2) others
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Ueno |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama-city, Japan
TEL
073-441-0613
shin-8@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Hayami |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama-city, Japan
TEL
073-441-0613
Homepage URL
shin-8@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
| 2017 | Year | 06 | Month | 17 | 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
| 2017 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
The aim of this study is to clarify risk factors for POUR and estimate the appropriate timing of removal of urethral catheter.
Management information
Registered date
| 2017 | Year | 06 | Month | 17 | Day |
Last modified on
| 2018 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031851
| 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 |
