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Norwegian Laparoscopic Aortic Surgery Trial (NLAST)

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ClinicalTrials.gov Identifier: NCT01793662
Recruitment Status : Recruiting
First Posted : February 15, 2013
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Syed Sajid Hussain Kazmi, Oslo University Hospital

Brief Summary:

Patients with severe atherosclerotic occlusive disease can be operated with an aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, the vary 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 reconvalescence.

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 lesion shall be randomized to either totally laparoscopic aortobifemoral bypass operation (LABFB)or an open ABFB operation.


Condition or disease Intervention/treatment Phase
Aortobifemoral Bypass Aortoiliac Occlusive Disease TASC Type D Lesions Laparoscopic Versus Open Bifurcation Graft Procedure: Laparoscopic aortobifemoral bypass Not Applicable

Detailed Description:

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

Secondary end points are as follows,

  • health related quality of life examined and evaluated with the help of pre and post-operative survey performed with the help of SF36v2 questionnaire and EQ5D5L.
  • peri operative stress response (during operation) measured/ analysed with the help of stress hormones changes
  • cost utility analysis
  • comparison of 3D and 2D laparoscopy,
  • etc.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Norwegian Laparoscopic Aortic Surgery Trial
Study Start Date : February 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

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




Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
    Post operative complications(early- within 30 days) shall be registered and analyzed in the two groups of patients. However, late complications shall also be registered although not defined as the primary end-point of the NLAST study.


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793662


Contacts
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Contact: Syed Sajid H Kazmi, MD, PhD 004792468309 sshkazmi@gmail.com
Contact: Jørgen J Jørgensen, MD, PhD 004795286086 j.j.jorgensen@medisin.uio.no

Locations
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Norway
Department of vascular surgery, Oslo University Hospital Recruiting
Oslo, Norway
Contact: Syed Sajid Hussain Kazmi, MD, PhD    004792468309    sshkazmi@gmail.com   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Syed Sajid Hussain Kazmi, MD, PhD Department of vascular surgery, Oslo University Hospital, Oslo, Norway

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Responsible Party: Syed Sajid Hussain Kazmi, Consultant Surgeon, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01793662    
Other Study ID Numbers: NLAST2012
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Syed Sajid Hussain Kazmi, Oslo University Hospital:
Aortobifemoral bypass
Laparoscopic aortic surgery
Aortoiliac occlusive disease
TASC Type D Lesions
Open aortic surgery
Additional relevant MeSH terms:
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Leriche Syndrome
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases