Clinical Trial: Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Laparoscopic Aortic Surgery: Norwegian Experiance

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 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.

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.


Sponsor: Oslo University Hospital

Current Primary Outcome: Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity) [ Time Frame: 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.



Original Primary Outcome: No residual symptoms of claudication intermittent among patients with aorto-iliac occlusive disease and no residual or recurrent aneurysm among patients operated for AAA one year post-operatively [ Time Frame: 2011-2020 ]

Current Secondary Outcome: Operative time, operative bleeding, length of hospital stay, quality of life [ Time Frame: 2005-2015 ]

Linear regression model was used to control for the confounding effect of the secondary continuous outcomes.


Original Secondary Outcome: All cause mortality per- and post-operatively [ Time Frame: 2011-2020 ]

Information By: Oslo University Hospital

Dates:
Date Received: December 13, 2010
Date Started: September 2010
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016