UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000946 |
|---|---|
| Receipt number | R000001135 |
| Scientific Title | Clinical evaluation of postoperative quality-of-life in the open mesh repair for inguinal hernia |
| Date of disclosure of the study information | 2007/12/14 |
| Last modified on | 2009/11/13 01:53:26 |
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Basic information
Public title
Clinical evaluation of postoperative quality-of-life in the open mesh repair for inguinal hernia
Acronym
Evaluation of postoperative quality-of-life in the open mesh repair for inguinal hernia.
Scientific Title
Clinical evaluation of postoperative quality-of-life in the open mesh repair for inguinal hernia
Scientific Title:Acronym
Evaluation of postoperative quality-of-life in the open mesh repair for inguinal hernia.
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the postoperative pain, complication, and quality-of-life between groups using PHS or Mesh-plug in the inguinal herniorraphy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison study of quality-of-life in the patients 1, 3, 6 and 12 month after the operation using SF-36.
Key secondary outcomes
Comparison study of postoperative pain (1, 2, 3, 7 day and 1, 3, 6, 12 month after the operation), complication and recurrence.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
PROLENE* Hernia System (sterilized by EO sterilizing) for herniorraphy.
Approved Number; 20400BZY00787000
Interventions/Control_2
BARD mesh (plug) (sterilized by EO sterilizing) for herniorraphy.
Approved Number; 16000BZY01128000
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 30 years or over.
New-onset hernia classified as inguinal hernia (by the criteria established in 2006/Apr. by Japan hernia research association).
1. indirect inguinal hernia
I-1, I-2, I-3
2. direct inguinal hernia
II-1, II-2, II-3
3. indirect and direct inguinal hernia
IV
Key exclusion criteria
1. Pregnant
2. The case with pneumonitis, peritonitis, ileus, perforation, intraperitoneally infection or urinary infection.
3. The case with Bleed, clotting disorder, wound healing disorder.
4. The case with mental illness such as depression and dementia.
5. Relapsing hernia
6. Incarcerated hernia which cannot be reduced.
7. The case with peripheral nerve disorder.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Hibi |
Organization
Showa university fujigaoka hospital
Division name
Surgery
Zip code
Address
1-30, fujigaoka, aoba-ku, yokohama-city, kanagawa, Japan
TEL
045-971-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taketo Matsubara |
Organization
Showa university fujigaoka hospital
Division name
Surgery
Zip code
Address
1-30, fujigaoka, aoba-ku, yokohama-city, kanagawa, Japan
TEL
045-971-1151
Homepage URL
t.matsubara@showa-university-fujigaoka.gr.jp
Sponsor or person
Institute
Showa university fujigaoka hospital Surgery, 1-30, fujigaoka, aoba-ku, yokohama-city, kanagawa, Japan
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2007 | Year | 12 | Month | 14 | 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
| 2007 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 13 | Day |
Last modified on
| 2009 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001135
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
