UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023203
Receipt No. R000026699
Scientific Title Diagnostic accuracy of ultrasound estimation of residual urine volume by nurses, in postoperative patients of gynecological cancer
Date of disclosure of the study information 2016/07/21
Last modified on 2019/09/08 (Ver. 6)

* 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 Diagnostic accuracy of ultrasound estimation of residual urine volume by nurses, in postoperative patients of gynecological cancer
Acronym Diagnostic accuracy of ultrasound estimation of residual urine volume by nurses, in postoperative patients of gynecological cancer
Scientific Title Diagnostic accuracy of ultrasound estimation of residual urine volume by nurses, in postoperative patients of gynecological cancer
Scientific Title:Acronym Diagnostic accuracy of ultrasound estimation of residual urine volume by nurses, in postoperative patients of gynecological cancer
Region
Japan

Condition
Condition postoperative voiding disorders
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 As radical operation for cervical or endometrial cancer, gynecological oncologists perform semi radical hysterectomy and radical hysterectomy. Urination disorders such as the loss of micturition desire or the increase in residual urine volume are at risk of appearing after these operation. In our hospital, the nurses evaluate residual urine volume by urethral catheterization. For evaluation of the residual urine volume, nurses could use simplified devices (BLADDER SCAN), but it doesn not have good accuracy for postoperative patient with gynecological cancer because of retention of lymph fluid or ascites. If nurses come to be able to evaluate the residual urine by the ultrasonic measurement, the burden on patient may be largely reduced. However, few reports of the precision of the residual urine estimation by the ultrasonic measurement by the nurse, have been reported yet, and it is necessary to inspect the diagnostic efficacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic accuracy of ultrasound estimation of residual urine volume using catheterization as a golden standard
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 ultrasound estimation of residual urine volume by nurses
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria patients who are scheduled to undergo semi-radical or radical hysterectomy/tracherectomy and/or opatoperative patient
Key exclusion criteria The patients under 20 years old
The patients who does not receive explanation about urination disorders
The patients who did not agree
The patients who are not appropriate for ultrasound estimation, such as those who have surgical site infection on abdominal incision.
The patients who should be inserted a ureteral catheter by underlying diseases or postoperative complications.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Miki
Middle name
Last name Miki
Organization Keio university hospital
Division name Department of nursing
Zip code 1608582
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3719
Email m.kamoshita@adst.keio.ac.jp

Public contact
Name of contact person
1st name Miki
Middle name
Last name Kataoka
Organization Keio university hospital
Division name Department of nursing
Zip code 1608582
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3719
Homepage URL
Email m.kamoshita@adst.keio.ac.jp

Sponsor
Institute Department of nursing, Keio university hospital
Institute
Department

Funding Source
Organization None
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 Keio University IRB
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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
2016 Year 07 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://jsgo.or.jp/60/common/program.pdf
Number of participants that the trial has enrolled 60
Results 
The diagnostic accuracy, sensitivity and specificity of ultrasonic estimation judging less than 100ml or more was 69.5%, 54.9% and 91.5%, respectively. The accuracy may be improved by nurses experiences. The error value was larger when residual urine volume was less than 100ml and lymphedema existed. It is considered difficult to utilize ultrasound as a screening tool due to its low sensitivity. It may be useful by patient selections and training of nurse practitioners..
Results date posted
2019 Year 09 Month 08 Day
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
2016 Year 05 Month 17 Day
Date of IRB
2016 Year 07 Month 19 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 17 Day
Last modified on
2019 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026699