Norwegian Laparoscopic Aortic Surgery Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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Norwegian Laparoscopic Aortic Surgery Trial

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

Intervention / Treatment
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* Procedure: Laparoscopic aortobifemoral bypass


Participation Criteria
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Eligibility Criteria
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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%
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open aortobifemoral bypass<br>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<br>* 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.<br>* Other names: laparoscope;|
| Experimental: Laparoscopic aortobifemoral bypass<br>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<br>* 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.<br>* Other names: laparoscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortobifemoral bypass, Laparoscopic aortic surgery, Aortoiliac occlusive disease, TASC Type D Lesions, Open aortic surgery