Aorto Iliac Occlusive Disease
Conditions
Keywords
laparoscopic aortic surgery, aorto-iliac occlusive disease
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELaparoscopic vs open Ygraft
Patients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared.
Sponsors
Sykehuset Ostfold
Sorlandet Hospital HF
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
All patients with a TASC D lesion in the aorto-iliac segment not amenable to or previously unsuccessfully treated by endovascular approach.
Exclusion criteria
* Unsuitable for surgery due to general health status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity) | 2005-2015 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time, operative bleeding, length of hospital stay, quality of life | 2005-2015 | Linear regression model was used to control for the confounding effect of the secondary continuous outcomes. |
Countries
Norway
Outcome results
None listed