UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010131 |
|---|---|
| Receipt number | R000010740 |
| Scientific Title | Research on morphological change which influences patency rate and incidence of a processus vaginalis. |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2013/02/27 18:18:58 |
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Basic information
Public title
Research on morphological change which influences patency rate and incidence of a processus vaginalis.
Acronym
Research on morphological change which influences patency rate and incidence of aPV.
Scientific Title
Research on morphological change which influences patency rate and incidence of a processus vaginalis.
Scientific Title:Acronym
Research on morphological change which influences patency rate and incidence of aPV.
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reserchi on morphological change which influences latency rate and incidence of processes vaginalis during laparoscopic surgery.
Basic objectives2
Others
Basic objectives -Others
Observation study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Appearance rate of inguinal hernia
Key secondary outcomes
Patency rate of the processus vaginalis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 0 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing laparoscopic surgery at the hospital and related hospital
Key exclusion criteria
Patients with a history of inguinal hernia
The patient who has to perform adhesiolysis for inguinal region observation during the surgery
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama medical university
Division name
second department of surgery
Zip code
Address
811-1 Kimiidera,Wakayama Japan
TEL
(073)447-2300
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Watanabe |
Organization
Wakayama medical university
Division name
second department of surgery
Zip code
Address
811-1 Kimiidera,Wakayama Japan
TEL
(073)447-2300
Homepage URL
Sponsor or person
Institute
Wakayama medical university
second department of surgery
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university
second department of surgery
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 01 | 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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Reserch on morphological change which influences latency rate and incidence of processes vaginalis during laparoscopic surgery
Management information
Registered date
| 2013 | Year | 02 | Month | 27 | Day |
Last modified on
| 2013 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010740
