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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035040
Receipt No. 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 2019/05/06

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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 (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
Email 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
Email takeuro@saitama-med.ac.jp

Sponsor
Institute Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Department of Urology, Saitama Medical Center, Saitama Medical University
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 Saitama Medical Center Ethics Comittee, Saitama Medical University
Address Kamoda 1981, Kawagoe, Saitama, Japan
Tel 81492283902
Email 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 Open public 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
2022 Year 03 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
2019 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039950

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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