UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040468 |
|---|---|
| Receipt number | 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 | 2024/11/24 23:50:20 |
* 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 postoperative day 2 or 3, before removing the epidural anesthesia catheter.
Interventions/Control_2
Late group: Urethral catheter removed after 2-24 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
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
tpsundaysilence@yahoo.co.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
Southern Tohoku General Hospital Certified Review Board
Address
7-115 Yatsuyamada, Koriyama City, Fukushima, Japan
Tel
024-934-5322
kensyu@mt.strins.or.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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
73
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
Main results already published
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
| 2025 | 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
| 2024 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046193
