UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036080 |
|---|---|
| Receipt number | 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 21:34:06 |
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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
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
yokota.notiko@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040549
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