UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035040 |
|---|---|
| Receipt number | R000039950 |
| Scientific Title | Clinical efficacy and safety of scrotal cooling, tunica albuginea incision and ischemic postconditioning for treating testicular torsion. |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2024/03/03 11:03:35 |
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Basic information
Public title
Clinical efficacy and safety of scrotal cooling, tunica albuginea incision and ischemic postconditioning for treating testicular torsion.
Acronym
Trimodality therapy for testicular torsion.
Scientific Title
Clinical efficacy and safety of scrotal cooling, tunica albuginea incision and ischemic postconditioning for treating testicular torsion.
Scientific Title:Acronym
Trimodality therapy for testicular torsion.
Region
| Japan |
Condition
Condition
Testicular torsion
Classification by specialty
| Pediatrics | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of scrotal cooling, tunica albuginea incision, and ischemic postconditioning for treating testicular torsion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Testicular salvage rate
Key secondary outcomes
Testicular volume (1,3,6,12m postoperatively)
Testicular blood flow (1,3,6,12m postoperatively)
Serum antisperm antibodies (3,12m postoperatively)
Complications of treatment (1,3,6,12m postoperatively)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After diagnosis of testicular torsion, the patient's scrotum will be cooled with an ice bag until entering the operating room.
After surgical detorsion, if testicular blood flow is seen by color Doppler ultrasound, ischemic postconditioning (three cycles of 30 sec reperfusion-30 sec ischaemia) will be performed.
After surgical detorsion, if testicular blood flow is not seen by color Doppler ultrasound, incision will be made on tunica albuginea. If testicular blood flow is seen after incision, ischemic postconditioning (three cycles of 30 sec reperfusion-30 sec ischaemia) will be performed. Then tunica vaginalis flap coverage and orchidopexy will be done. If testicular blood flow is not seen even after incision, orchiectomy will be done.
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
Key inclusion criteria
The patient who presents with testicular torsion at our institution
Key exclusion criteria
The patient or the proxy who does not consent with this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Takeshita |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Urology
Zip code
3508550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
81492283673
takeuro@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Takeshita |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Urology
Zip code
3508550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
81492283673
Homepage URL
takeuro@saitama-med.ac.jp
Sponsor or person
Institute
Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical Center Ethics Comittee, Saitama Medical University
Address
Kamoda 1981, Kawagoe, Saitama, Japan
Tel
81492283902
smcrinri@saitama-med.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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039950
