Norwegian Laparoscopic Aortic Surgery Trial

NCT ID: NCT01793662

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2026-12-30

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

Conditions

Aortobifemoral Bypass; Aortoiliac Occlusive Disease; TASC Type D Lesions; Laparoscopic Versus Open Bifurcation Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open 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.

Group Type: ACTIVE_COMPARATOR

Laparoscopic aortobifemoral bypass

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Laparoscopic aortobifemoral bypass

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Laparoscopic aortic surgery; laparoscope

Eligibility Criteria

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%

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Syed Sajid Hussain Kazmi

Consultant Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Syed Sajid Hussain Kazmi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of vascular surgery, Oslo University Hospital, Oslo, Norway

Locations

Department of vascular surgery, Oslo University Hospital

Oslo, , Norway

Countries

Norway

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NLAST2012

Identifier Type: -

Identifier Source: org_study_id