UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Appropriate timing of removal of epidural and urethral catheters to avoid postoperative urinary retention undergoing abdominal surgery
Title of the study (Brief title)	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	Masaki Ueno
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama-city, Japan
TEL	073-441-0613
Email	shin-8@wakayama-med.ac.jp

Public contact
Name of contact person	Shinya Hayami
Organization	Wakayama Medical University
Division name	Second Department of Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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