Norwegian Laparoscopic Aortic Surgery Trial

Not Applicable

Active, not recruiting

• Conditions: Aortobifemoral Bypass; Aortoiliac Occlusive Disease; TASC Type D Lesions; Laparoscopic Versus Open Bifurcation Graft
• Interventions: Procedure: Laparoscopic aortobifemoral bypass

• Registration Number: NCT01793662
• Lead Sponsor: Oslo University Hospital

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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-08
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 126

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic aortobifemoral bypass	Laparoscopic aortobifemoral bypass	Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.
Open aortobifemoral bypass	Laparoscopic aortobifemoral bypass	Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation.

Primary Outcome Measures

Name	Time	Method
Postoperative complications	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of vascular surgery, Oslo University Hospital; 🇳🇴 Oslo, Norway