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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027796
Receipt No. 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

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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
Email 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
Email shin-8@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031851

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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