Norwegian Laparoscopic Aortic Surgery Trial

Aortoiliac Occlusive Disease Clinical Trial

— NLAST  

Official title:

Norwegian Laparoscopic Aortic Surgery Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01793662
• Other study ID #: NLAST2012
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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%

Related Conditions & MeSH terms

• Aortobifemoral Bypass
• Aortoiliac Occlusive Disease
• Laparoscopic Versus Open Bifurcation Graft
• Leriche Syndrome
• TASC Type D Lesions

Intervention

Procedure:
• Laparoscopic 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.

Locations

Country	Name	City	State
Norway	Department of vascular surgery, Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative stress response	During operation changes in the stress hormones e.g., adrenalin, cortisol etc shall be analyzed in the two patients groups.	During operation
Other	Cost utility examination	In hospital cost of the treatment shall be calculated. Cost utility examination shall be performed.	30 days
Other	Inflammatory stress response	Changes in the pro-inflammatory interleukins etc shall be registered during and after operation.	30 days
Primary	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	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