Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

NCT02325700 | Completed DMC

• 1 other identifier: JBR02
• Study Type: observational
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Graft Occlusion, Vascular

Outcome Measures

Primary Outcomes (1)

• Composite adverse events (bypass occlusion, bleeding, graft infection, redo)

  Any of these complications occurring during this time frame

  0 to 6 years postoperative

Secondary Outcomes (1)

• Mortality

  0 to 6 years postoperative

Study Arms (2)

Open aortic repair

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

Procedure: Aortic repair

Laparoscopic aortic repair

83 patients with Laparoscopic aortic repair for abdominal aortic aneurysmal disease (n=30) or abdominal aortic occlusive disease (n=53)

Procedure: Aortic repair

Interventions

Aortic repair PROCEDURE

Aortic bypass

Laparoscopic aortic repair; Open aortic repair

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Aortic occlusive disease (TASC C \& D)
• Aortic abdominal aneurysm with a diameter \> 5 cm

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Poitiers: lead

Related Publications (2)

• 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.

  PMID: 28644602 DERIVED

• 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.

  PMID: 27102201 DERIVED

MeSH Terms

Conditions

Graft Occlusion, Vascular

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Jean-Baptiste Ricco, MD, PhD

  CHU, University of Poitiers, medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: December 25, 2014
• Study Start: January 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2014
• Last Updated: December 25, 2014

Record last verified: 2014-12