Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

Graft Occlusion, Vascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325700
• Other study ID #: JBR02
• 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

• Aortic Diseases
• Graft Occlusion, Vascular

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