Clinical trial NCT02325700: Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease
Official title: Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease. A Prospective Study With Propensity Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft Occlusion, Vascular
Lead sponsor: University of Poitiers
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 228
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite adverse events (bypass occlusion, bleeding, graft infection, redo)
timeFrame: 0 to 6 years postoperative
Secondary outcomes:
measure: Mortality
timeFrame: 0 to 6 years postoperative
Other outcomes:
Locations:
Study officials:
affiliation: CHU, University of Poitiers, medical school
name: Jean-Baptiste Ricco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.