UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003710 |
|---|---|
| Receipt number | R000004491 |
| Scientific Title | Randomized clinical trial assessing impact of a heavyweight or lightweight mesh on chronic pain after inguinal hernia repair by mesh-plug method |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2014/09/17 11:21:13 |
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Basic information
Public title
Randomized clinical trial assessing impact of a heavyweight or lightweight mesh on chronic pain after inguinal hernia repair by mesh-plug method
Acronym
Efficacy of a lightweight mesh in inguinal hernia repair
Scientific Title
Randomized clinical trial assessing impact of a heavyweight or lightweight mesh on chronic pain after inguinal hernia repair by mesh-plug method
Scientific Title:Acronym
Efficacy of a lightweight mesh in inguinal hernia repair
Region
| Japan |
Condition
Condition
Adult cases of inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether the chronic pain after inguinal hernia repair by mesh-plug method can be suppressed by the use of lightweight mesh, compared with conventional heavyweight mesh.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Occurrence and/or magnitude of chronic pain and discomfort after inguinal hernia repair.
Key secondary outcomes
Recurrence of hernia
Occurrence of postoperative infectious complications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of the lightweight mesh
Interventions/Control_2
Use of the heavyweight mesh
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases scheduled to undergo inguinal hernia repair in Nagoya Daini Red Cross Hospital
Key exclusion criteria
In case other surgical management than mesh-plug method is employed.
Strangulation of hernia.
Cases of recurrent hernia.
In case lumber anesthesia is needed.
Those who underwent hernia repair of the other side within a year.
Those who needed a constant use of painkillers due to other chronic diseases.
In case significant changes are needed in the planning of surgery (e.g. femoral hernia).
Those who cannot understand the concept of the study (e.g. dementia or mental disorders).
Patients who cannot respond our scheduled questionnaire after the surgery.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichiro Komatsu |
Organization
Nagoya Daini Red Cross Hospital
Division name
Surgery
Zip code
Address
2-9, Myoukencho, Showaku, Nagoya City, Aichi Pref.
TEL
052-832-1121
skomat@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunichiro Komatsu |
Organization
Nagoya Daini Red Cross Hospital
Division name
Surgery
Zip code
Address
2-9, Myoukencho, Showaku, Nagoya City, Aichi Pref.
TEL
052-832-1121
Homepage URL
skomat@nagoya2.jrc.or.jp
Sponsor or person
Institute
Nagoya Daini Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Ethicon, Inc., Somerville, New Jersey
Organization
Division
Category of Funding Organization
Profit organization
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
名古屋第二赤十字病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s10029-013-1105-8
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
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 04 | Day |
Last modified on
| 2014 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004491
