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NCT Number: NCT01793662

Norwegian Laparoscopic Aortic Surgery Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of vascular surgery, Oslo University Hospital

Oslo, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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%

Treatment and study plan

Laparoscopic aortobifemoral bypass

Procedure

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

Primary outcomes

  1. Postoperative complications

    Time frame: 2.9 years

    Postoperative complications during a mean follow-up period of 2.9 years are the primary outcome measure of NLAST.

Secondary outcomes

  1. health related quality of life

    Time frame: 3 months postoperatively

    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.

Other outcomes

  1. Operative stress response

    Time frame: During operation

    During operation changes in the stress hormones e.g., adrenalin, cortisol etc shall be analyzed in the two patients groups.

  2. Cost utility examination

    Time frame: 30 days

    In hospital cost of the treatment shall be calculated. Cost utility examination shall be performed.

  3. Inflammatory stress response

    Time frame: 30 days

    Changes in the pro-inflammatory interleukins etc shall be registered during and after operation.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: NLAST

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2013
Registry last updated
Jul 3, 2025

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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