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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041625
Receipt No. 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 2020/09/03

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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, 2021
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
Email 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
Email akiyamata@yamanashi.ac.jp

Sponsor
Institute University of Yamanashi
Institute
Department

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
Email 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
2021 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
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047498

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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