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CompletedNCT02325700Updated Dec 25, 2014

Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

An observational study in Graft Occlusion, Vascular, sponsored by University of Poitiers. Completed. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-25.

Sponsored by University of Poitiers · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
228
Ages
30 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Graft Occlusion, Vascular

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In context

Aortic Diseases

99 studies on the registry are indexed under Aortic Diseases; 42 are open to participants now.

This study's enrollment of 228 is above the median of 192 across 61 observational studies indexed under Aortic Diseases.

Browse Aortic Diseases studies →

Lead sponsor

University of Poitiers is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
228 participants (actual)
Target follow-up
6 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • ProcedureAortic repair

    Aortic bypass

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What researchers measure

Primary outcomes

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

    Any of these complications occurring during this time frame

    Time frame: 0 to 6 years postoperative

Secondary outcomes

  1. Mortality

    Any death occurring within the first 30 days and after

    Time frame: 0 to 6 years postoperative

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 27102201 ↗
  • 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. PubMed 28644602 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02325700
Lead sponsor
University of Poitiers
Responsible party
Sponsor
First posted
Dec 25, 2014
Start date
Jan 2006
Primary completion
Jan 2010
Completion
Dec 2014
Last update
Dec 25, 2014

Study contacts

Jean-Baptiste Ricco, MD, PhD
principal investigator · CHU, University of Poitiers, medical school

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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