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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name