The objective of this study is to evaluate the usefulness of closing the abdomen with a prosthetic mesh after laparotomy for aortic aneurysm repair or in patients with a BMI larger than 27 in order to prevent an incisional hernia. The aim is to…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ventrale hernias na laparotomie (chirurgische complicatie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome
· Incisional hernia occurrence
Secondary outcome
Secondary outcome
· Postoperative complications
· Pain
· Quality of life
· Cost effectiveness
Background summary
Incisional hernia is the most common longterm complication in abdominal
surgery. In about 10 to 20 % of all patients receiving abdominal surgery, an
incisional hernia will develop. In teh Netherlands this leads to about 5000
incisional hernia corrections each year.
Some high risk groups have a very incidence of incisional hernia: aortic
aneurysm patients and patients having an BMI larger than 27. About 30 % of
these patients will develop an incisional hernia.
Up to this dat only small studies have been performed to investigate the
effectiveness of preventive mesh placement. The results are hopefull, but a
randomised controlled trial had not yet been performed.
Study objective
The objective of this study is to evaluate the usefulness of closing the
abdomen with a prosthetic mesh after laparotomy for aortic aneurysm repair or
in patients with a BMI larger than 27 in order to prevent an incisional hernia.
The aim is to reduce the risk of incisional hernia after laparotomy in the
study group from 30 % to 10 %.
Study design
This is a double blinded randomized controlled trial. Before surgery, patients
will be randomized either to receive primary closure with a suture or primary
closure with a prosthetic mesh.
A total 480 patients will be randomized into 3 groupes.
Intervention
During the closure of the abdomen a mesh will be placed on or in the abdominal
wall.
Study burden and risks
The intervention will take place during surgery and will delay the surgery
approximately 15 minutes. The risks consit of wound complications related to
mesh placement. Surgical site infection and seroma formation are the most
important complications. However, these are mild and respond well to therapy.
The benefit of mesh placement is the reduction of the incidence of incisional
hernia formation from 30 to 10 %.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Every elective midline laparotomy for patients with Abdominal Aortic Aneurysm and patients with a BMI of more than 27.
Exclusion criteria
· Age < 18 years
· Emergency procedure
· Inclusion in other trials
· Aortic reconstruction for obstructive disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL18461.078.07 |