Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
JPRN |
Last refreshed on:
|
17 October 2023 |
Main ID: |
JPRN-UMIN000005453 |
Date of registration:
|
20/10/2011 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Mesh Fixation with Cyanoacrylate in the Open Repair of Inguinal Hernia. A Comparative Study
|
Scientific title:
|
Mesh Fixation with Cyanoacrylate in the Open Repair of Inguinal Hernia. A Comparative Study - Cyanoacrylate vs Suture Fixation of Mesh in Inguinal Hernia Repair |
Date of first enrolment:
|
2010/09/01 |
Target sample size:
|
250 |
Recruitment status: |
Recruiting |
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006467 |
Study type:
|
Interventional |
Study design:
|
Parallel Randomized
|
Phase:
|
Phase II
|
|
Countries of recruitment
|
Europe
| | | | | | | |
Contacts
|
Name:
|
ADEL ELDABE |
Address:
|
AV. CID CAMPEADOR 95, 09005 BURGOS
Japan |
Telephone:
|
|
Email:
|
|
Affiliation:
|
HOSPITAL GENERAL YAGUE, BURGOS SPAIN GENERAL SURGERY |
|
Name:
|
|
Address:
|
Japan |
Telephone:
|
|
Email:
|
|
Affiliation:
|
HOSPITAL GENERAL YAGUE, BURGOS GENERAL SURGERY |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: Recurrent inguinal hernias Emergency hernia surgery Large inguinoscrotal hernias Chronic preoperative inguinal pain Unavailability for follow up
Age minimum:
16years-old
Age maximum:
80years-old
Gender:
Male and Female
|
Health Condition(s) or Problem(s) studied
|
Comparing outcome after inguinal hernia repair with mesh using cyanoacrylate or suture for mesh fixation
|
Intervention(s)
|
Suture Fixation of Mesh Cyanoacrylate Fixation of Mesh
|
Primary Outcome(s)
|
Chronic inguinal pain after hernia repair
|
Secondary Outcome(s)
|
Hernia recurrences Short term morbidity Length of postoperative hospital stay Time off work
|
Source(s) of Monetary Support
|
GENERAL SURGERY DEPARTMENT HOSPITAL GENERAL YAGUE BURGOS, SPAIN
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|