SHIFT

Project description

Stoma hernia develops in 3–80% in patients with stoma. In surgery for stoma hernia, methods are currently used where a synthetic strengthening mesh is placed under the abdominal muscle around the stoma, or inside the abdominal cavity around the stoma. The methods often give relapses of the stoma hernia, in addition, the mesh can give rise to troublesome complications such as fistulas between the intestine and the mesh. The most widely used method today is to put the net inside the abdominal cavity, as this method seems to give fewer relapses, but in international guidelines there are no clear recommendations due to the lack of high-quality studies. 
The research group has developed a method where the patient's own full skin is used as reinforcement in surgery for stoma hernia. This new surgical method is evaluated in the SHIFT (Stoma Hernia Intraperitoneal Full-Thickness skin) study. It is a randomized multicenter study where a synthetic enhancement material (Dynamesh IPST)™ is compared with the patient's own full skin when operating on symptomatic ostomy hernia. The primary comparison is surgical complications, but we will also evaluate the study participants' quality of life and pain, incidence of relapse and health economics. The method may mean that endogenous material, for which a foreign body reaction is absent, could be used in a very difficult-to-treat condition. In addition, some of the networks used today are expensive, and the method could result in significant cost savings. 
In parallel with the main study, tissue samples will also be collected in connection with the primary surgery and blood samples at the clinical follow-ups. In these samples, the study participants' connective tissue and connective tissue turnover will be studied. It will teach us more about the underlying causes of hernia disease and enable a more tailored treatment. 

Objective/Aims

• Through a randomized prospective multicenter study, evaluate whether prophylactically inlaid mesh reinforcement around a newly constructed end colostomy can prevent PSB.
• To map the occurrence and outcome of surgery methods to correct PSB in Sweden.
• To map the cost of stomas both in terms of ostomy material and visits to healthcare and compare groups with and without parastomal hernia.
• Through qualitative study methodology, create a picture of the patient's own experience of what it is like to live with a stoma both with and without a parastomal hernia.