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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02325700
Other study ID # JBR02
Secondary ID
Status Completed
Phase N/A
First received December 21, 2014
Last updated December 21, 2014
Start date January 2006
Est. completion date December 2014

Study information

Verified date December 2014
Source University of Poitiers
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 228
Est. completion date December 2014
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Aortic repair
Aortic bypass

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Poitiers

Outcome

Type Measure Description Time frame Safety issue
Primary Composite adverse events (bypass occlusion, bleeding, graft infection, redo) Any of these complications occurring during this time frame 0 to 6 years postoperative No
Secondary Mortality Any death occurring within the first 30 days and after 0 to 6 years postoperative No
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