NCT01793662

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Feb 2013Dec 2026

Study Start

First participant enrolled

February 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

13.9 years

First QC Date

February 14, 2013

Last Update Submit

June 30, 2025

Conditions

Aortobifemoral BypassAortoiliac Occlusive DiseaseTASC Type D LesionsLaparoscopic Versus Open Bifurcation Graft

Keywords

Aortobifemoral bypassLaparoscopic aortic surgeryAortoiliac occlusive diseaseTASC Type D LesionsOpen aortic surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Postoperative complications during a mean follow-up period of 2.9 years are the primary outcome measure of NLAST.

    2.9 years

Secondary Outcomes (1)

  • health related quality of life

    3 months postoperatively

Other Outcomes (3)

  • Operative stress response

    During operation

  • Cost utility examination

    30 days

  • Inflammatory stress response

    30 days

Study Arms (2)

Open aortobifemoral bypass

ACTIVE COMPARATOR

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

Procedure: Laparoscopic aortobifemoral bypass

Laparoscopic aortobifemoral bypass

EXPERIMENTAL

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

Procedure: Laparoscopic aortobifemoral bypass

Interventions

Laparoscopic aortobifemoral bypassPROCEDURE

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.

Also known as: Laparoscopic aortic surgery, laparoscope
Laparoscopic aortobifemoral bypassOpen aortobifemoral bypass

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aortoiliac occlusive disease (TASC Type D lesions)

You may not qualify if:

  • Active cancer disease
  • Acute critical limb ischemia
  • Prior major abdominal surgery
  • Heart failure (Ejection fraction \<40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of vascular surgery, Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

  • Kazmi SSH, Sahba M, Pettersen EM, Krog AH, Fagerland MW, Sundhagen JO. Norwegian Randomised Trial of Laparoscopic versus Open Aortobifemoral Bypass: The Norwegian Laparoscopic Aortic Surgery Trial (NLAST). Eur J Vasc Endovasc Surg. 2025 Nov 7:S1078-5884(25)00932-3. doi: 10.1016/j.ejvs.2025.09.046. Online ahead of print.

    PMID: 41207501DERIVED

MeSH Terms

Interventions

Laparoscopes

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Syed Sajid Hussain Kazmi, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations

NO(1)