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OpenTrials
Completed

NCT Number: NCT02325700

Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

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.

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Key information

Conditions

Graft Occlusion, Vascular Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aortic repair

Procedure

Aortic bypass

Primary outcomes

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

    Time frame: 0 to 6 years postoperative

    Any of these complications occurring during this time frame

Secondary outcomes

  1. Mortality

    Time frame: 0 to 6 years postoperative

    Any death occurring within the first 30 days and after

Sponsors and collaborators

Lead sponsor

University of Poitiers

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2014
First posted
Dec 25, 2014
Registry last updated
Dec 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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