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

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 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


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

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
Registered date File name

Research case data
Registered date File name