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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02325700
Enrollment
228
Registered
2014-12-25
Start date
2006-01-31
Completion date
2014-12-31
Last updated
2014-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Occlusion, Vascular

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.

Interventions

PROCEDUREAortic repair

Aortic bypass

Sponsors

University of Poitiers
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite adverse events (bypass occlusion, bleeding, graft infection, redo)0 to 6 years postoperativeAny of these complications occurring during this time frame

Secondary

MeasureTime frameDescription
Mortality0 to 6 years postoperativeAny death occurring within the first 30 days and after

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026