Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

NCT ID: NCT02325700

Last Updated: 2014-12-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 228 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Graft Occlusion, Vascular

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Open aortic repair

145 patients with open aortic repair for abdominal aortic aneurysmal disease (n=139) or abdominal aortic occlusive disease (n=89)

Aortic repair

Intervention Type: PROCEDURE

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)

Aortic repair

Intervention Type: PROCEDURE

Aortic bypass

Interventions

Aortic repair

Aortic bypass

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Poitiers

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Baptiste Ricco, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU, University of Poitiers, medical school

References

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.

Reference Type: DERIVED

PMID: 28644602 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27102201 (View on PubMed)

Other Identifiers

JBR02

Identifier Type: -

Identifier Source: org_study_id