Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia

Plasma alpha Glutathione S transferase

This study compares the plasma Alpha GST in patients with CMI (n=30) and MALS (n=30) with those with 1-Morbus Crohn (n=30), 2-Gallstone disease (n=30), and age-matched healthy individuals (n=60). After inclusion in the study, blood tests will be performed to exclude renal failure and liver disease. Venous blood samples will be obtained before and 3 months after treatment in the patients with CMI and MALS. Blood samples will also be obtained from the individuals in the control groups twice ( at inclusion and 3 months apart ). The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique. The plasma levels of Alpha GST in ng/mL before and after the intervention will be compared seperately for the differnt study groups.

Health related quality of life (QoL)

Changes in the health-related quality of life (QoL) will be investigated. EuroQol 5D (EQ5D) questionnaire, which is a generic tool, will be used to assess the QoL of the study patients. EQ5D is a generic tool for the assessment of health related quality of life and is translated to Norwegian language and validated tool for the assessmeent of changes in the health related quality of life. The patients will fill out the EQ5D at inclusion in the study and 1, 2, 5, and 10 years after treatment of CMI and MALS in the patient groups. EQ5D has 5 questions with 5 levels of answers to each question. Level 1 will denote the best possible health status and level 5 denotes the worst health status for each of the 5 questions. It allows to a assess both physical and mental quality of health of the patients.

Clinical outcomes of the treatment of CMI and MALS

Effect of treatment on the symptoms of CMI and MALS postoperatively at 30 and 90 days, and at 1, 2, 5 and 10 years. A study specific questionnaire has been deveolped to register the signs and symptoms of CMI and MALS. The patients in the study will fill-out the questionnaire before and after the treatment and will repeat it at every follow-up time-point. The patients in the study will be follow-up by the clinicians who are not directly involved with the study and therefore the clinical information obtained will be standarized and made independent of the clinician's background. The questionnaire will allow to assess if the clinical symptoms have improved or worsen during the follow-up.

Cost utility analysis of the treatment of CMI and MALS

Quality adjusted life years (QALY ) estimation of the surgical and endovascular treatment of the patients with CMI and MALS. The costs of the treatment during the hospital stay will be calculated, compared with the costs of treatment given by the Norwegian Directorate of Health, QALY will be calculated based on the EQ5D results and the estimated treatment costs.

Intestinal ishemia biomarkers for CMI and MALS

Secondary outcome mesure: Plasma levels of intestinal fatty acid binding protein (iFABP) in ng/mL. In the previous studies, this biomarker has been demonstrated to be raised in the plasma of patients with CMI. Venous blood obtained fra the study individuals before and 3 months after the treatment of CMI and MALS will be analyzed with ELISA technique to discover any changes in these plasma biomarkers of ischemia. The groups will be compared for the changes in the individual plasma levels of these biomarkers and tested for any association to intestinal ischemia.