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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036080
Receipt No. R000040549
Scientific Title Usefulness and safety of contralateral PPV closure using electro coagulation method for pediatric inguinal hernia
Date of disclosure of the study information 2019/03/25
Last modified on 2019/03/04

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Basic information
Public title Usefulness and safety of contralateral PPV closure using electro coagulation method for pediatric inguinal hernia
Acronym Usefulness and safety of contralateral PPV closure using electro coagulation method for pediatric inguinal hernia
Scientific Title Usefulness and safety of contralateral PPV closure using electro coagulation method for pediatric inguinal hernia
Scientific Title:Acronym Usefulness and safety of contralateral PPV closure using electro coagulation method for pediatric inguinal hernia
Region
Japan

Condition
Condition pediatric inguinal hernia
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate whether PPV electrocautery can be applied to contralateral inguinal hernia against contralateral PPV 2.3 versus pediatric inguinal hernia to prevent onset of contralateral inguinal hernia.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation is made on the effectiveness of electrocautery, in which contralateral onset of inguinal hernia does not occur by electrocautery of the contralateral PPV 2,3 type.
Key secondary outcomes Evaluate the safety of electrocautery, which enables safe onset of contralateral side of inguinal hernia by electrocautery of contralateral PPV 2,3type.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We examined patients with pediatric surgery and pediatric endoscopic surgery at the Tokushima University hospital, who were diagnosed as unilateral inguinal hernia, underwent LPEC and recognized contralateral PPV type 2,3. To the contralateral PPV, electrocautery is performed to investigate whether it can prevent contralateral onset.
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
15 years-old >
Gender Male and Female
Key inclusion criteria Do palpation of the inguinal region (clinical findings: there is bulging). Also, confirm the PPV continuous with the peritoneum by ultrasonic examination. However, ultrasonic examination is not an essential criterion.

Key exclusion criteria A case of inguinal hernia recurrence or other gross operation with other surgery.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ishibashi
Organization Tokushima University hospital
Division name Pediatric surgery
Zip code
Address Tokushima prefecture Kuramoto town 3-18-15
TEL 07065860166
Email hiroki@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Yokota
Organization Tokushima University hospital
Division name Pediatric surgery
Zip code
Address Tokushima prefecture Kuramoto town3-18-15
TEL 07065860173
Homepage URL
Email yokota.notiko@tokushima-u.ac.jp

Sponsor
Institute Tokushima University hospital
Institute
Department

Funding Source
Organization Tokushima University hospital Pediatric Surgery
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 3392
Org. issuing International ID_1 The University of Tokushima Hospital Clinical Management Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 25 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
2019 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 04 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040549

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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