Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451893
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2007-03-23
Brief Title:
The Significance of the Mesh Thickness in the Operation of Inguinal Hernia
Sponsor:
Umeå University
Organization:
Umeå University
Study Overview
Official Title:
An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LJUNO
Brief Summary:
The trial compares the postoperative complain pain quality of life after the implantation of a heavy-weight alternative light-weight mesh by randomly allocating patients with inguinal hernia disease to two groups of surgeons each group being trained to operate with one of the above mentioned meshes
Hypothesis There is less postoperative pain after the implantation of a light-weight mesh
Hypothesis There is less postoperative pain after the implantation of a light-weight mesh
Detailed Description:
The implantation of mesh in the operation of inguinal hernia has resulted in a continuously diminishing frequency of reoperations Randomized controlled trials indicate that hernia repair with an open mesh technique has a shorter learning curve is cheaper and may give less recurrences than laparoscopic hernia repair in general surgical practice Furthermore local anesthesia has significant advantages for both the patient and the health related economy compared to general anesthesia and regional anesthesia The experience of the last decade within the field of groin hernia surgery has focused interest on quality of life and postoperative pain especially chronic pain Chronic pain is defined as pain that remains 3 months after the operation Recent studies indicate that one third of all patients operated on for inguinal hernia have some degree of chronic pain and that 4-6 of patients have pain interfering with daily activities one year after surgery
In the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh In an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons each group well trained to use one of the two meshes
In the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh In an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons each group well trained to use one of the two meshes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None