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

This study is currently recruiting participants.
Verified January 2012 by Austrian Hernia Study Group
Sponsor:
Information provided by (Responsible Party):
PD Dr. Herwig Pokorny, Austrian Hernia Study Group
ClinicalTrials.gov Identifier:
NCT01507870
First received: January 5, 2012
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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 Intervention
Incisional Hernia
Obesity
Procedure: onlay mesh placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Austrian Hernia Study Group:

Primary Outcome Measures:
  • incisional hernia occurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    haematoma formation, seroma formation, surgical site infection (SSI - classification)

  • postoperative pain [ Time Frame: 14 days postoperative ] [ Designated as safety issue: No ]
    VAS

  • life quality [ Time Frame: 14 days postoperative ] [ Designated as safety issue: No ]
    MOS SF-36


Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507870

Contacts
Contact: Herwig E Pokorny, PD Dr 00432622321 herwig.pokorny@wienerneustadt.lknoe.at

Locations
Austria
Recruiting
Wiener Neustadt, Lower Austria, Austria, 2700
Contact: Herwig E Pokorny, PD Dr    00432622321    herwig.pokorny@wienerneustadt.lknoe.at   
Principal Investigator: Herwig E Pokorny, PD Dr         
Sponsors and Collaborators
Austrian Hernia Study Group
  More Information

No publications provided

Responsible Party: PD Dr. Herwig Pokorny, Principal Investigator, Austrian Hernia Study Group
ClinicalTrials.gov Identifier: NCT01507870     History of Changes
Other Study ID Numbers: Primary Onlay
Study First Received: January 5, 2012
Last Updated: January 10, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Austrian Hernia Study Group:
body mass index

Additional relevant MeSH terms:
Hernia
Obesity
Pathological Conditions, Anatomical
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014