Abstract
BackgroundIncisional hernia is the most frequently seen long term complication after laparotomy causing much morbidity and even mortality. The overall incidence remains 11-20%, despite studies attempting to optimize closing techniques. Two patient groups, patients with abdominal aortic aneurysm and obese patients, have a risk for incisional hernia after laparotomy of more than 30%. These patients might benefit from mesh augmented midline closure as a means to reduce incisional hernia incidence.Methods/designThe PRImary Mesh Closure of Abdominal Midline Wound (PRIMA) trial is a double-blinded international multicenter randomized controlled trial comparing running slowly absorbable suture closure with the same closure augmented with a sublay or onlay mesh. Primary endpoint will be incisional hernia incidence 2 years postoperatively. Secondary outcomes will be postoperative complications, pain, quality of life and cost effectiveness.A total of 460 patients will be included in three arms of the study and randomized between running suture closure, onlay mesh closure or sublay mesh closure. Follow-up will be at 1, 3, 12 and 24 months with ultrasound imaging performed at 6 and 24 months to objectify the presence of incisional hernia. Patients, investigators and radiologists will be blinded throughout the whole follow up.DisccusionThe use of prosthetic mesh has proven effective and safe in incisional hernia surgery however its use in a prophylactic manner has yet to be properly investigated. The PRIMA trial will provide level 1b evidence whether mesh augmented midline abdominal closure reduces incisional hernia incidence in high risk groups.Trial registrationClinical trial.gov NCT00761475.
Highlights
Incisional hernia is the most frequently seen long term complication after laparotomy causing much morbidity and even mortality
Incisional hernia surgery is, a re-operation to relieve symptoms caused by this common complication and the results of repair are often disappointing [7,8]
The objective of this study is to evaluate the effectiveness of incisional hernia prevention in patients after laparotomy for aortic aneurysm and in obese patients with a BMI of more than 27
Summary
Incisional hernia is the most frequently seen long term complication after laparotomy causing much morbidity and even mortality. Incisional hernia (IH) is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients [1,2,3,4]. Patient-related risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking, abdominal aortic aneurysm (AAA), and connective tissue disorders are known [7,9,10,11,12,13]. Despite this knowledge a sufficient method for prevention, has not been developed yet. Interest in prevention of incisional hernias with the aid of synthetic mesh is growing and small, yet promising studies have been published [14,15,16,17,18,19,20,21,22,23,24,25]
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