Norwegian Laparoscopic Aortic Surgery Trial (NLAST)

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Aortobifemoral Bypass; TASC Type D Lesions; Aortoiliac Occlusive Disease; Laparoscopic Versus Open Bifurcation Graft

Treatments: Procedure: Laparoscopic aortobifemoral bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT01793662

NLAST2012

Details and patient eligibility

About

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.

Full 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

Enrollment: 126 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aortoiliac occlusive disease (TASC Type D lesions)

Exclusion criteria

• Active cancer disease
• Acute critical limb ischemia
• Prior major abdominal surgery
• Heart failure (Ejection fraction <40%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Open aortobifemoral bypass

Active Comparator group

Description:

Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.

Treatment:

Procedure: Laparoscopic aortobifemoral bypass

Laparoscopic aortobifemoral bypass

Experimental group

Description:

Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.

Treatment:

Procedure: Laparoscopic aortobifemoral bypass