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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.
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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic aortobifemoral bypass | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Postoperative complications during a mean follow-up period of 2.9 years are the primary outcome measure of NLAST. | 2.9 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cost utility examination | In hospital cost of the treatment shall be calculated. Cost utility examination shall be performed. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syed Sajid Hussain Kazmi, MD, PhD | Department of vascular surgery, Oslo University Hospital, Oslo, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of vascular surgery, Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41207501 | Derived | Kazmi SSH, Sahba M, Pettersen EM, Krog AH, Fagerland MW, Sundhagen JO. Editor's Choice - Norwegian Randomised Trial of Laparoscopic versus Open Aortobifemoral Bypass: The Norwegian Laparoscopic Aortic Surgery Trial (NLAST). Eur J Vasc Endovasc Surg. 2026 Mar;71(3):374-383. doi: 10.1016/j.ejvs.2025.09.046. Epub 2025 Nov 7. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2013 | Jun 30, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2025 | Jun 30, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D020706 | Laparoscopes |
| ID | Term |
|---|---|
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
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|
| 30 days |
| Inflammatory stress response | Changes in the pro-inflammatory interleukins etc shall be registered during and after operation. | 30 days |