Randomized Controlled Prospective Multicenter Study Primary Onlay- Mesh After Elective Median Laparotomy in Patients With BMI ≥ 27
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|ClinicalTrials.gov Identifier: NCT01507870|
Recruitment Status : Terminated
First Posted : January 11, 2012
Last Update Posted : July 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Incisional Hernia Obesity||Procedure: onlay mesh placement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
|Active Comparator: prophylactic onlay mesh||
Procedure: onlay mesh placement
prophylactic onlay mesh in patients with median laparotomy
No Intervention: continuous running suture
continuous running suture of the linea alba
- incisional hernia occurrence [ Time Frame: 3 years ]
- complications [ Time Frame: 3 years ]haematoma formation, seroma formation, surgical site infection (SSI - classification)
- postoperative pain [ Time Frame: 14 days postoperative ]VAS
- life quality [ Time Frame: 14 days postoperative ]MOS SF-36
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507870
|Wiener Neustadt, Lower Austria, Austria, 2700|