Background
Incisional hernias are defects of the fascia of the abdominal wall, covered by skin, which can develop after abdominal surgery. Bulging through the scar is visible and palpable when patients are standing or coughing. These hernias occur in at least 15% of patients after open abdominal surgery within ten years after surgery. Incisional hernias may be asymptomatic, but frequently they cause pain and give aesthetic complaints. They can also cause serious complications like strangulation of the bowel. The quality of life in these patients as well as their chances for employment is reduced.
Pre-disposing factors to get an incisional hernia are obesity, which is increasing rapidly in the Western world, and a post-operative surgical site infection. There are no differences between men and women in developing an incisional hernia. Ethnical differences are not known. The pathogenesis of incisional hernias is complex; altered collagen metabolism and extra-cellular matrix disorders causing wound-healing disorders have been found in patients who developed incisional hernias.
A population based study showed a 3,7% yearly increase in the incidence of incisional hernia repair per 10.000 people in the United States. Since obesity plays an important role in developing an incisional hernia and is an increasing problem in the Netherlands, we expect the incidence of incisional hernias to increase in the Netherlands as well. Mean age at time of the surgical repair is 58 years old, mean SD 15 years. The majority of these patients will have to go back to work.
Eighty percent of the patients with an incisional hernia undergo surgical repair. The morbidity of open incisional hernia repair is more than 20% involving recurrence and mesh infection. Laparoscopic surgery tends to be safe and is associated with less infections and shorter hospitalization. It is highly feasible in obese patients, because of a good exposure of the incisional hernia. However, the surgical procedure can be difficult and the operating time might be longer. Up till now it is not clear what is the best treatment strategy for incisional hernias. The potential benefits of a more defined treatment strategy includes a shorter hospital admission, cost reduction and less post-operative complications.
Two recent meta-analysis state that laparoscopic repair is at least as effective and might be superior to the open approach in a number of outcomes. Total hospital stay was shorter and less post-operative complications were seen. The largest study in the meta-analysis has several shortcomings; randomization is not listed and there was no sample size calculation. Most studies only provide short-term follow-up evaluation and cost-effectiveness is not evaluated. This study, comparing the cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed.
Criteria to recommend a surgical repair should be stated and the natural course of an incisional hernia should be examined.
This is a multi-centre study with surgeons who are experienced in open as well as laparoscopic surgery. The study group exists of dedicated laparoscopic surgeons, committed to improve hernia-care. First, we want to know if laparoscopic repair is more effective than open repair. The future of this study will allow evidence-based change of practice.