Clinical Trial: Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]
Official Title: Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease. A Prospective Study With Propensity Analysis
Brief Summary: This prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using a propensity analysis model.
Detailed Summary: From January 2006 to January 2010, 228 consecutive patients who received an aortic bypass for AAA (n=139) or for AOD (n=89) were studied. Open repair was performed in145 patients (AAA=109, AOD=36) and total laparoscopic repair in 83 patients (AAA=30, AOD=53). One-to-one propensity score matching between study groups was done according to a difference in the logit of propensity score of less than 0.04 between each patient pairs in the study groups. Logistic regression with the help of backward selection was used to adjust the effect of treatment method for propensity score as well as other variables in evaluating postoperative and long-term outcome. A p value < .05 was considered statistically significant.
Sponsor: University of Poitiers
Current Primary Outcome: Composite adverse events (bypass occlusion, bleeding, graft infection, redo) [ Time Frame: 0 to 6 years postoperative ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Mortality [ Time Frame: 0 to 6 years postoperative ]
Original Secondary Outcome: Same as current
Information By: University of Poitiers
Dates:
Date Received: December 21, 2014
Date Started: January 2006
Date Completion:
Last Updated: December 21, 2014
Last Verified: December 2014