UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055629 |
|---|---|
| Receipt number | R000063572 |
| Scientific Title | Investigation of risk factors for the occurrence of the obturator nerve reflex during transurethral resection of bladder tumors under spinal anesthesia |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2024/09/26 10:37:42 |
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Basic information
Public title
Investigation of risk factors for the occurrence of the obturator nerve reflex during transurethral resection of bladder tumors under spinal anesthesia
Acronym
Investigation of risk factors for the occurrence of the obturator nerve reflex during transurethral resection of bladder tumors under spinal anesthesia
Scientific Title
Investigation of risk factors for the occurrence of the obturator nerve reflex during transurethral resection of bladder tumors under spinal anesthesia
Scientific Title:Acronym
Investigation of risk factors for the occurrence of the obturator nerve reflex during transurethral resection of bladder tumors under spinal anesthesia
Region
| Japan |
Condition
Condition
Bladder tumor
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the risk factors for the occurrence of the obturator nerve reflex during transurethral resection of bladder tumor (TURBT). By analyzing the factors that lead to the transition from spinal anesthesia to general anesthesia, it may be possible to predict in advance which cases are at high risk of a obturator nerve reflex, and this may be useful for preoperative planning for TURBT.
Basic objectives2
Others
Basic objectives -Others
Investigating risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the change from spinal anesthesia to general anesthesia and patient factors, surgical methods, and anesthesia methods
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
TURBT
Key exclusion criteria
1. Surgery scheduled under general anesthesia
2. Patients with errors or missing data in their main data
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
Translational Research & Development Organization
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
+81-29-853-3914
shimada.kensuke.gu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
Translational Research & Development Organization
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
+81-29-853-3914
Homepage URL
shimada.kensuke.gu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
Tel
+81-29-853-3914
shimada.kensuke.gu@u.tsukuba.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
| 2024 | Year | 09 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the dataset created by the "Large-scale observational study on the quality of perioperative care using perioperative dataset from the University of Tsukuba Hospital (R03-068)".
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063572
