Norwegian Laparoscopic Aortic Surgery Trial (NLAST)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortoiliac Occlusive Disease; Aortobifemoral Bypass; TASC Type D Lesions; Laparoscopic Versus Open Bifurcation Graft
• Intervention / Treatment: Procedure: Laparoscopic aortobifemoral bypass

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Department of vascular surgery, Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open aortobifemoral bypass; Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.	Procedure: Laparoscopic aortobifemoral bypass; Totally laparoscopic aortobifemoral bypass shall be performed and the patients in this intervention arm shall be compared with the control arm randomized for open aortobifemoral bypass operation.; Other Names: Laparoscopic aortic surgery; laparoscope
Experimental: Laparoscopic aortobifemoral bypass; Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.	Procedure: Laparoscopic aortobifemoral bypass; Totally laparoscopic aortobifemoral bypass shall be performed and the patients in this intervention arm shall be compared with the control arm randomized for open aortobifemoral bypass operation.; Other Names: Laparoscopic aortic surgery; laparoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications during a mean follow-up period of 2.9 years are the primary outcome measure of NLAST.	2.9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
health related quality of life	The bodily pain domain of the SF36-v2 at 3 months postoperatively shall be used to assess the patients in the two groups of NLAST study. Besides EQ-5D-5L shall be used pre and post operatively for QoL evaluation.	3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative stress response	During operation changes in the stress hormones e.g., adrenalin, cortisol etc shall be analyzed in the two patients groups.	During operation
Cost utility examination	In hospital cost of the treatment shall be calculated. Cost utility examination shall be performed.	30 days
Inflammatory stress response	Changes in the pro-inflammatory interleukins etc shall be registered during and after operation.	30 days

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Syed Sajid Hussain Kazmi, MD, PhD, Department of vascular surgery, Oslo University Hospital, Oslo, Norway

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 14, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimated): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Open aortic surgery; Aortobifemoral bypass; Laparoscopic aortic surgery; Aortoiliac occlusive disease; TASC Type D Lesions
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Aortic Diseases; Leriche Syndrome
• Other Study ID Numbers: NLAST2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED