Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478348
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2007-05-22
Brief Title:
Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not
Sponsor:
University of Lausanne Hospitals
Organization:
University of Lausanne Hospitals
Study Overview
Official Title:
Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection seromas and hematomas
Detailed Description:
Between 3 to 20 of patients who received a midline laparotomy will develop an incisional hernia
Primary suture of the defect is associated with a recurrence rate between 25 and 50Mesh repair is superior with regard to the recurrence 12-20 but early postoperative complications include infections hematomas and seromas
Some advocate the use of drains in order to diminish secretions and complications Other claim that drains increase the complications rate
In the absence of a randomized controlled trial its not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia
The aim of this study is to answer this question comparing prospectively two groups of operated patients the former with drainage and the latter without
Primary suture of the defect is associated with a recurrence rate between 25 and 50Mesh repair is superior with regard to the recurrence 12-20 but early postoperative complications include infections hematomas and seromas
Some advocate the use of drains in order to diminish secretions and complications Other claim that drains increase the complications rate
In the absence of a randomized controlled trial its not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia
The aim of this study is to answer this question comparing prospectively two groups of operated patients the former with drainage and the latter without
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