Clinical Trial: Norwegian Laparoscopic Aortic Surgery Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Norwegian Laparoscopic Aortic Surgery Trial

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.


Detailed Summary:

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.

Sponsor: Oslo University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Oslo University Hospital

Dates:
Date Received: February 14, 2013
Date Started: February 2013
Date Completion: January 2023
Last Updated: April 3, 2017
Last Verified: April 2017