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 2023/11/23 20:20:41

* 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

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 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

Email

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

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

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

2023 Year 11 Month 23 Day



Link to view the page

Value
https://center6.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