Randomized Controlled Prospective Multicenter Study Primary Onlay- Mesh After Elective Median Laparotomy in Patients With BMI ≥ 27

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01507870
Recruitment Status : Terminated
First Posted : January 11, 2012
Last Update Posted : July 2, 2015
Information provided by (Responsible Party):
PD Dr. Herwig Pokorny, Austrian Hernia Study Group

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. incisional hernia occurrence [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. complications [ Time Frame: 3 years ]
    haematoma formation, seroma formation, surgical site infection (SSI - classification)

  2. postoperative pain [ Time Frame: 14 days postoperative ]

  3. life quality [ Time Frame: 14 days postoperative ]
    MOS SF-36

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Every elective midline laparotomy for patients with a BMI of more than 27. Signed informed consent

Exclusion Criteria:

  • Age < 18 years
  • Emergency procedure
  • Inclusion in other trials
  • Previous midline incision
  • Life expectancy less than 24 months
  • Pregnant women
  • Immune suppression therapy within 2 weeks before surgery

Information from the National Library of Medicine

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 identifier (NCT number): NCT01507870

Wiener Neustadt, Lower Austria, Austria, 2700
Sponsors and Collaborators
Austrian Hernia Study Group

Responsible Party: PD Dr. Herwig Pokorny, Principal Investigator, Austrian Hernia Study Group Identifier: NCT01507870     History of Changes
Other Study ID Numbers: Primary Onlay
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: July 2015

Keywords provided by PD Dr. Herwig Pokorny, Austrian Hernia Study Group:
body mass index

Additional relevant MeSH terms:
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes