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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01507870
Other study ID # Primary Onlay
Secondary ID
Status Terminated
Phase N/A
First received January 5, 2012
Last updated July 1, 2015
Start date January 2010
Est. completion date January 2013

Study information

Verified date July 2015
Source Austrian Hernia Study Group
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 300
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
onlay mesh placement
prophylactic onlay mesh in patients with median laparotomy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Austrian Hernia Study Group

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary incisional hernia occurrence 3 years No
Secondary complications haematoma formation, seroma formation, surgical site infection (SSI - classification) 3 years No
Secondary postoperative pain VAS 14 days postoperative No
Secondary life quality MOS SF-36 14 days postoperative No
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