Norwegian Laparoscopic Aortic Surgery Trial (NLAST)

University of Oslo (UIO) logo

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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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