Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT01793662 |
Other study ID # |
NLAST2012 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 2013 |
Est. completion date |
December 30, 2026 |
Study information
Verified date |
March 2024 |
Source |
Oslo University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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