UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041625 |
|---|---|
| Receipt number | R000047498 |
| Scientific Title | A Prospective Observational Study of Effective Epidural Insertion Site for Catheter-related Bladder Discomfort after Transurethral Resection of Prostate |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/08/31 11:11:41 |
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Basic information
Public title
A Prospective Observational Study of Effective Epidural Insertion Site for Catheter-related Bladder Discomfort after Transurethral Resection of Prostate
Acronym
A Prospective Observational Study of Effective Epidural Insertion Site for CRBD after TURP
Scientific Title
A Prospective Observational Study of Effective Epidural Insertion Site for Catheter-related Bladder Discomfort after Transurethral Resection of Prostate
Scientific Title:Acronym
A Prospective Observational Study of Effective Epidural Insertion Site for CRBD after TURP
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Benign prostatic hyperplasia causes frequent urination and straining to void in the elderly and reducing the quality of life (QOL). Transurethral resection of the prostate (TURP) is the common treatment for benign prostatic hyperplasia. The indwelling urinary catheter is placed for bleeding monitoring and preventing urinary retention after TURP. However, the catheter-related bladder discomfort (CRBD) is develops at a high rate postoperatively, and it contributes to lower postoperative satisfaction. To prevent CRBD, we use patient-controlled analgesia (PCA) with epidural catheter at the time of TURP. However, the most effective epidural puncture site for CRBD after TURP has not yet been investigated. In the present study, we seek to investigate the effective epidural insertion site (Th12/L1 versus sacral fissure) for catheter-related bladder discomfort after TURP at our institution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity of postoperative CRBD
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Patients who meet all of the following
1, Patients undergoing TURP under general anesthesia from September 1, 2020 to August 31, 2022
2, ASA physical status class 1-3
3, Patients using patient controlled epidural analgesia in postoperative period
4, Patients between the ages of 50 and less than 90
5, Patients who can obtain written consent to participate in this study
Key exclusion criteria
Patients who have any of the following
1, Patients with heart failure of NYHA 3 or greater
2, Patients with respiratory failure of Hugh-Jones 3 or greate
3, Patients with mental illness
4, Patients with chronic pain
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tadahiko |
| Middle name | |
| Last name | Ishiyama |
Organization
University of Yamanashi Hospital
Division name
Surgical center
Zip code
409-3898
Address
1110 Shimokato, Chuo-shi, Yamanashi
TEL
055-273-9690
ishiyama@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Akiyama |
Organization
Faculty of Medicine, University of Yamanashi
Division name
Department of Anesthesiology
Zip code
409-3898
Address
1110 Shimokato, Chuo-shi, Yamanashi
TEL
055-273-9690
Homepage URL
akiyamata@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee of Faculty of Medicine, University of Yamanashi
Address
1110 Shimokato, Chuo-shi, Yamanashi
Tel
055-273-9065
rec-med@yamanashi.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 | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The severity of CRBD will be classified into four levels: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) at 6, 12, and 24 hours after surgery in the two groups where epidural catheterization was performed at Th12/L1 and at the sacral fissure.
Management information
Registered date
| 2020 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047498
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