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Completed

NCT Number: NCT01259908

Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease

Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.

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Key information

Conditions

Aorto Iliac Occlusive Disease

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.

Secondary endpoints like length of hospital stay, operation time, bleeding time shall also be considered.

Besides short form- 36 (SF-36) shall be used for the evaluation of patients health related quality of life, preoperatively,1,3,and 6 months and 1 year post-operatively.

Early, midterm and long time results shall be followed.

Who can participate

Healthy volunteers accepted: No

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

All patients with a TASC D lesion in the aorto-iliac segment not amenable to or previously unsuccessfully treated by endovascular approach.

Exclusion criteria

  • Unsuitable for surgery due to general health status

Treatment and study plan

Laparoscopic vs open Ygraft

Procedure

Patients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared.

Primary outcomes

  1. Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity)

    Time frame: 2005-2015

    Composite endpoint defined as all-cause mortality, systemic morbidity and graft thrombosis.

    In this prospective comparative cohort study 50 consecutive patients with type D atherosclerotic lesions in the aortoiliac segment were treated with laparoscopic aortobifemoral bypass operation. The group was compared with 30 patients operated with open aortobifemoral bypass operations for the same disease and period of time. The groups were compared on the basis of composite endpoint All-cause mortality, graft occlusion and systemic morbidity). Stratification analysis was performed by using Mantel-Haenszel method with the patient time model. Cox multivariate regression method was used to adjust for confounding effect after considering the proportional hazard assumption. Cox proportional cause-specific hazard regression model was used for competing risk endpoints. Comparison of survival curves was done with the help of log- rank test.

Secondary outcomes

  1. Operative time, operative bleeding, length of hospital stay, quality of life

    Time frame: 2005-2015

    Linear regression model was used to control for the confounding effect of the secondary continuous outcomes.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Sorlandet Hospital HF
  • Sykehuset Ostfold

Registry information

Official study title

Laparoscopic Aortic Surgery: Norwegian Experiance

Acronym: LAS

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2010
Registry last updated
Jun 22, 2023

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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