Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease. A Prospective Study With Propensity Analysis

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.

Study Overview

• Status: Completed
• Conditions: Graft Occlusion, Vascular
• Intervention / Treatment: Procedure: Aortic repair

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 Type: Observational
• Enrollment (Actual): 228

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients presenting with an abdominal aortic aneurysm or an occlusive aortic disease operated from January 2006 to January 2010.

Open repair was performed in145 patients (AAA=109, AOD=36) Total laparoscopic repair was performed in 83 patients (AAA=30, AOD=53).

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open aortic repair; 145 patients with open aortic repair for abdominal aortic aneurysmal disease (n=139) or abdominal aortic occlusive disease (n=89)	Procedure: Aortic repair; Aortic bypass
Laparoscopic aortic repair; 83 patients with Laparoscopic aortic repair for abdominal aortic aneurysmal disease (n=30) or abdominal aortic occlusive disease (n=53)	Procedure: Aortic repair; Aortic bypass

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Any death occurring within the first 30 days and after	0 to 6 years postoperative

Collaborators and Investigators

• Sponsor: University of Poitiers
• Investigators: Principal Investigator: Jean-Baptiste Ricco, MD, PhD, CHU, University of Poitiers, medical school

Publications and helpful links

General Publications

• Ricco JB, Cau J, Biancari F, Desvergnes M, Lefort N, Belmonte R, Schneider F. Outcome After Open and Laparoscopic Aortic Surgery in Matched Cohorts Using Propensity Score Matching. Eur J Vasc Endovasc Surg. 2016 Aug;52(2):179-88. doi: 10.1016/j.ejvs.2016.02.021. Epub 2016 Apr 18.
• Ricco JB, Cau J, Schneider F, Desvergnes M, Lefort N, Belmonte R. Chirurgie aortique totalement laparoscopique ou par laparotomie: comparaison des resultats apres appariement par un score de propension. Bull Acad Natl Med. 2016 Mar;200(3):527-40; discussion 540-3. French.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 21, 2014
• First Submitted That Met QC Criteria: December 21, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Estimate): December 25, 2014
• Last Update Submitted That Met QC Criteria: December 21, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Aortic Diseases; Graft Occlusion, Vascular
• Other Study ID Numbers: JBR02