Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.
Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality. Secondary endpoints like length of hospital stay, operation time, bleeding time shall also be considered. Besides short form- 36 (SF-36) shall be used for the evaluation of patients health related quality of life, preoperatively,1,3,and 6 months and 1 year post-operatively. Early, midterm and long time results shall be followed.
Study Type
OBSERVATIONAL
Enrollment
80
Patients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared.
Oslo University Hospital
Oslo, Norway
Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity)
Composite endpoint defined as all-cause mortality, systemic morbidity and graft thrombosis. In this prospective comparative cohort study 50 consecutive patients with type D atherosclerotic lesions in the aortoiliac segment were treated with laparoscopic aortobifemoral bypass operation. The group was compared with 30 patients operated with open aortobifemoral bypass operations for the same disease and period of time. The groups were compared on the basis of composite endpoint All-cause mortality, graft occlusion and systemic morbidity). Stratification analysis was performed by using Mantel-Haenszel method with the patient time model. Cox multivariate regression method was used to adjust for confounding effect after considering the proportional hazard assumption. Cox proportional cause-specific hazard regression model was used for competing risk endpoints. Comparison of survival curves was done with the help of log- rank test.
Time frame: 2005-2015
Operative time, operative bleeding, length of hospital stay, quality of life
Linear regression model was used to control for the confounding effect of the secondary continuous outcomes.
Time frame: 2005-2015
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