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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000946
Receipt No. 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

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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
Email

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
Email t.matsubara@showa-university-fujigaoka.gr.jp

Sponsor
Institute Showa university fujigaoka hospital Surgery, 1-30, fujigaoka, aoba-ku, yokohama-city, kanagawa, Japan
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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