Norwegian Laparoscopic Aortic Surgery Trial — NLAST  

Aortoiliac Occlusive Disease Clinical Trial

Official title: Norwegian Laparoscopic Aortic Surgery Trial

Status Active, not recruiting

Clinical Trial Summary

Patients with severe atherosclerotic occlusive disease can be operated on with an aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, this operation has also been performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive as compared to the open ABFB. The cohort studies published so far have shown that although a longer operation time with the laparoscopic procedure as compared to the open surgery, the patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic complications, and earlier convalescence.

However, no randomized control trial has yet been published to compare the two procedures.

In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC type D atherosclerotic lesions shall be randomized to either totally laparoscopic aortobifemoral bypass operation (LABFB)or an open ABFB operation.

Clinical Trial Description

The primary endpoint of the study is post-operative complications defined as systemic and local complications, including vascular complications e.g., graft infection, thrombosis, etc.

Secondary endpoints are as follows,

• health-related quality of life, examined and evaluated with the help of pre and post-operative surveys performed with the help of SF36v2 questionnaire and EQ5D5L.

• perioperative stress response (during operation) measured/analyzed with the help of stress hormones changes

• perioperative inflammatory response

• cost-utility analysis

• cost differences ;

Related Conditions & MeSH terms

• Aortobifemoral Bypass
• Aortoiliac Occlusive Disease
• Laparoscopic Versus Open Bifurcation Graft
• Leriche Syndrome
• TASC Type D Lesions

• NCT number: NCT01793662
• Study type: Interventional
• Source: Oslo University Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2013
• Completion date: December 30, 2026