Norwegian Laparoscopic Aortic Surgery Trial (NLAST)
Primary Purpose
Aortobifemoral Bypass, Aortoiliac Occlusive Disease, TASC Type D Lesions
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Laparoscopic aortobifemoral bypass
Sponsored by
About this trial
This is an interventional treatment trial for Aortobifemoral Bypass focused on measuring Aortobifemoral bypass, Laparoscopic aortic surgery, Aortoiliac occlusive disease, TASC Type D Lesions, Open aortic surgery
Eligibility 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%
Sites / Locations
- Department of vascular surgery, Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Open aortobifemoral bypass
Laparoscopic aortobifemoral bypass
Arm Description
Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.
Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.
Outcomes
Primary Outcome Measures
Postoperative complications
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
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.
Full Information
NCT ID
NCT01793662
First Posted
February 14, 2013
Last Updated
March 28, 2023
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01793662
Brief Title
Norwegian Laparoscopic Aortic Surgery Trial
Acronym
NLAST
Official Title
Norwegian Laparoscopic Aortic Surgery Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortobifemoral Bypass, Aortoiliac Occlusive Disease, TASC Type D Lesions, Laparoscopic Versus Open Bifurcation Graft
Keywords
Aortobifemoral bypass, Laparoscopic aortic surgery, Aortoiliac occlusive disease, TASC Type D Lesions, Open aortic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open aortobifemoral bypass
Arm Type
Active Comparator
Arm Description
Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.
Arm Title
Laparoscopic aortobifemoral bypass
Arm Type
Experimental
Arm Description
Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic aortobifemoral bypass
Other Intervention Name(s)
Laparoscopic aortic surgery, laparoscope
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
health related quality of life
Description
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.
Time Frame
3 months postoperatively
Other Pre-specified Outcome Measures:
Title
Operative stress response
Description
During operation changes in the stress hormones e.g., adrenalin, cortisol etc shall be analyzed in the two patients groups.
Time Frame
During operation
Title
Cost utility examination
Description
In hospital cost of the treatment shall be calculated. Cost utility examination shall be performed.
Time Frame
30 days
Title
Inflammatory stress response
Description
Changes in the pro-inflammatory interleukins etc shall be registered during and after operation.
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Sajid Hussain Kazmi, MD, PhD
Organizational Affiliation
Department of vascular surgery, Oslo University Hospital, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of vascular surgery, Oslo University Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Norwegian Laparoscopic Aortic Surgery Trial
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