Obesity Clinical Trial
Incisional hernia is one ot the most frequently seen long term complications in abdominal
surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for
incisional hernia after midline incision remains about 5-20 %. One major risk factor for
incisional hernia after a median laparotomy is obesity.
The closure technique of midline incisions has remained unchanged since many decades and
primarily consists of suturing the linea alba. Interest in prevention of incisional hernias
with the aid of synthetic mesh is growing and only one large randomized trial is active
recruiting patients in Germany, Netherlands and Belgium (Prima Trial).
Patients with a BMI of more than 27 have a high risk of developing an incisional hernia
after midline incision with an incidence of 22% after 12 months. This high risk group of
patients may benefit from prevention.
Some small studies have been performed to evaluate the usefulness and safety of primary
laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk
for incisional hernias and a low infection rate, even when used in contaminated wounds such
as colostomy surgery.
The goal of this study is to evaluate the effectiveness of incisional hernia prevention
after elective median laparotomy in patients with a BMI of more than 27. A randomized
controlled trial will be performed comparing the commonly used technique of running suture
to close with the aid of a prosthetic onlay mesh. The primary outcome measure will be
incisional hernia occurrence. Secondary outcome measures will be complications, surgical
site infections, post-operative pain and quality of life.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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