UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023203 |
|---|---|
| Receipt number | 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 18:13:03 |
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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
| Obstetrics 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
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
m.kamoshita@adst.keio.ac.jp
Sponsor or person
Institute
Department of nursing, Keio university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026699
