Primary Mesh Closure of Abdominal Midline Wounds

Phase 3

Completed

• Conditions: Incisional Hernia Occurence
• Interventions: Procedure: mesh supported closure; Procedure: primary closure

• Registration Number: NCT00761475
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. 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. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most 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 colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Study Start: 2009-02
• Primary Completion: 2012-12
• Study Completion: 2015-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years
• Emergency procedure
• Inclusion in other trials
• Aortic reconstruction for obstructive disease
• Life expectancy less than 24 months
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	mesh supported closure	sublay mesh supported closure
1	primary closure	primary closure of the midline
2	mesh supported closure	onlay mesh supported closure

Primary Outcome Measures

Name	Time	Method
incisional hernia occurence	2 years

Secondary Outcome Measures

Name	Time	Method
complications	1 month
post-operative pain	1 month
quality of life	2 years

Trial Locations

Locations (12)

Maxima Medisch Centrum; 🇳🇱 Veldhoven, Netherlands

Berlin-Charite Universitatsklinikum; 🇩🇪 Berlin, Germany

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Wilhelminenspital; 🇦🇹 Vienna, Austria

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Sint Franciscus Gasthuis; 🇳🇱 Rotterdam, Netherlands

Heidelberg University Medical Center; 🇩🇪 Heidelberg, Germany

Isala klinieken; 🇳🇱 Zwolle, Netherlands

IJsselland Ziekenhuis; 🇳🇱 Capelle a/d IJssel, Netherlands

Scheper Ziekenhuis; 🇳🇱 Emmen, Netherlands

Hamburg-Eppefdorf Universitatsklinikum; 🇩🇪 Hamburg, Germany

Munchen University Medical Center; 🇩🇪 Munchen, Germany