UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005453 |
|---|---|
| Receipt number | R000006467 |
| Scientific Title | Mesh Fixation with Cyanoacrylate in the Open Repair of Inguinal Hernia. A Comparative Study |
| Date of disclosure of the study information | 2011/10/20 |
| Last modified on | 2011/10/20 01:12:00 |
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Basic information
Public title
Mesh Fixation with Cyanoacrylate in the Open Repair of Inguinal Hernia. A Comparative Study
Acronym
Cyanoacrylate vs Suture Fixation of Mesh in Inguinal Hernia Repair
Scientific Title
Mesh Fixation with Cyanoacrylate in the Open Repair of Inguinal Hernia. A Comparative Study
Scientific Title:Acronym
Cyanoacrylate vs Suture Fixation of Mesh in Inguinal Hernia Repair
Region
| Europe |
Condition
Condition
Comparing outcome after inguinal hernia repair with mesh using cyanoacrylate or suture for mesh fixation
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of mesh fixation with cyanoacrylate in inguinal hernia repair regarding chronic neuralgia & recurrence & comparing outcome with suture fixation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Chronic inguinal pain after hernia repair
Key secondary outcomes
Hernia recurrences
Short term morbidity
Length of postoperative hospital stay
Time off work
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Suture Fixation of Mesh
Interventions/Control_2
Cyanoacrylate Fixation of 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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with inguinal hernia operated electively
Key exclusion criteria
Recurrent inguinal hernias
Emergency hernia surgery
Large inguinoscrotal hernias
Chronic preoperative inguinal pain
Unavailability for follow up
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ADEL ELDABE |
Organization
HOSPITAL GENERAL YAGUE, BURGOS
SPAIN
Division name
GENERAL SURGERY
Zip code
Address
AV. CID CAMPEADOR 95, 09005 BURGOS
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
HOSPITAL GENERAL YAGUE, BURGOS
Division name
GENERAL SURGERY
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
UNIDAD DE INVESTIGACION
Institute
Department
Personal name
Funding Source
Organization
GENERAL SURGERY DEPARTMENT
HOSPITAL GENERAL YAGUE
BURGOS, SPAIN
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
| 2011 | Year | 10 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | 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
Management information
Registered date
| 2011 | Year | 04 | Month | 16 | Day |
Last modified on
| 2011 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006467
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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