Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

Completed

• Conditions: Graft Occlusion, Vascular
• Interventions: Procedure: Aortic repair

• Registration Number: NCT02325700
• Lead Sponsor: University of Poitiers

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 Description

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2010-01
• Status Verified: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2014-12-21
• Study First Submitted QC: 2014-12-21
• Last Update Submitted: 2014-12-21
• Study First Posted: 2014-12-25
• Last Update Posted: 2014-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• Aortic occlusive disease (TASC C & D)
• Aortic abdominal aneurysm with a diameter > 5 cm

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Exclusion Criteria

• Patients with an occlusive disease amenable to stenting (TASC A & B)
• Patients with an abdominal aortic aneurysm with an anatomy allowing the use of a stent graft (EVAR)
• Patients with a life expectancy < 3 years or ASA 4 with a high operative risk

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open aortic repair	Aortic repair	145 patients with open aortic repair for abdominal aortic aneurysmal disease (n=139) or abdominal aortic occlusive disease (n=89)
Laparoscopic aortic repair	Aortic repair	83 patients with Laparoscopic aortic repair for abdominal aortic aneurysmal disease (n=30) or abdominal aortic occlusive disease (n=53)

Primary Outcome Measures

Name	Time	Method
Composite adverse events (bypass occlusion, bleeding, graft infection, redo)	0 to 6 years postoperative	Any of these complications occurring during this time frame

Secondary Outcome Measures

Name	Time	Method
Mortality	0 to 6 years postoperative	Any death occurring within the first 30 days and after