Aortobifemoral Bypass, Aortoiliac Occlusive Disease, Laparoscopic Versus Open Bifurcation Graft, TASC Type D Lesions
Conditions
Keywords
Aortobifemoral bypass, Laparoscopic aortic surgery, Aortoiliac occlusive disease, TASC Type D Lesions, Open aortic surgery
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
Interventions
PROCEDURELaparoscopic 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.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 2.9 years | Postoperative complications during a mean follow-up period of 2.9 years are the primary outcome measure of NLAST. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| health related quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative stress response | During operation | During operation changes in the stress hormones e.g., adrenalin, cortisol etc shall be analyzed in the two patients groups. |
| Cost utility examination | 30 days | In hospital cost of the treatment shall be calculated. Cost utility examination shall be performed. |
| Inflammatory stress response | 30 days | Changes in the pro-inflammatory interleukins etc shall be registered during and after operation. |
Countries
Norway
Outcome results
None listed