UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040468
Receipt No. R000046193
Scientific Title Appropriate timing of urethral catheter removal in gastrointestinal surgery with epidural anesthesia: a randomized controlled trial
Date of disclosure of the study information 2020/05/21
Last modified on 2020/05/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Appropriate timing of urethral catheter removal in gastrointestinal surgery with epidural anesthesia: a randomized controlled trial
Acronym Appropriate timing of urethral catheter removal in gastrointestinal surgery with epidural anesthesia
Scientific Title Appropriate timing of urethral catheter removal in gastrointestinal surgery with epidural anesthesia: a randomized controlled trial
Scientific Title:Acronym Appropriate timing of urethral catheter removal in gastrointestinal surgery with epidural anesthesia
Region
Japan

Condition
Condition Gastric and colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the appropriate timing of urethral catheter removal in gastrointestinal surgery with epidural anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Incidence of postoperative urinary retention
(POUR)
Key secondary outcomes 1) Development of urinary tract infection
2) Postoperative hospital stay
3) Degree of patient distress and disability to rehabilitation due to implantation of urethral catheters using questionnaires

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Early group: The urethral catheter is removed on the second postoperative day.

Interventions/Control_2 Late group: Urethral catheter removed after 2 hours of epidural catheter removal
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) A case of radical surgery for gastric cancer and colorectal cancer
2) A case of epidural catheterization with epidural anesthesia
3) A case of an indwelling urethral catheter
4) A case in which consent could be obtained
Key exclusion criteria 1) Not a scheduled surgery
2) Cases of rectal cancer (lower margin of tumor is Ra or Rb)
3) Epidural catheter is removed within 48 hours postoperatively
4)Dialysis patient
5) A case of preoperative urinary retention
6) A case after total bladder removal
7) A case after lower urethral surgery
8) A case who require a urologist or a urologic technician to insert the urinary catheter at the timing of surgery
9) A case in which an indwelling urethral catheter had been placed preoperatively
10) A case where a urinary tract infection was diagnosed preoperatively
11) Cases requiring continuation of indwelling urethral catheter for urine volume measurement
12) A case in which the attending physician determined that the epidural was not working at all
13) Cases in which epidural anesthesia is ineffective and requires sustained intravenous administration of opioids
14) A case of unintentional epidural catheter removal (self-extraction or spontaneous removal)
15) Postoperative cases requiring intensive care
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Teppei
Middle name
Last name Miyakawa
Organization Fukushima Medical University
Division name Minimally Invasive Surgical and Medical Oncology
Zip code 960-1295
Address 1 Hikariga-oka, Fukushima City, JAPAN
TEL 024-547-1111
Email tpsundaysilence@yahoo.co.jp

Public contact
Name of contact person
1st name Teppei
Middle name
Last name Miyakawa
Organization Fukushima Medical University
Division name Minimally Invasive Surgical and Medical Oncology
Zip code 960-1295
Address 1 Hikariga-oka, Fukushima City, JAPAN
TEL 024-547-1111
Homepage URL
Email tpsundaysilence@yahoo.co.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukushima Medical University Certified Review Board
Address 1 Hikariga-oka, Fukushima City, JAPAN
Tel 024-547-1825
Email fmucrb@fmu.ac.jp

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
2020 Year 05 Month 21 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 Open public recruiting
Date of protocol fixation
2019 Year 08 Month 13 Day
Date of IRB
2019 Year 10 Month 15 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 21 Day
Last modified on
2020 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.