Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease (LAS)

Laparoscopic Aortic Surgery: Norwegian Experiance

Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.

Study Overview

• Status: Completed
• Conditions: Aorto Iliac Occlusive Disease
• Intervention / Treatment: Procedure: Laparoscopic vs open Ygraft

Detailed Description

Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.

Secondary endpoints like length of hospital stay, operation time, bleeding time shall also be considered.

Besides short form- 36 (SF-36) shall be used for the evaluation of patients health related quality of life, preoperatively,1,3,and 6 months and 1 year post-operatively.

Early, midterm and long time results shall be followed.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with aorto-iliac occlusive disease (Type D lesion according to the Trans Atlantic Intersociety Consensus TASC II)

Description

All patients with a TASC D lesion in the aorto-iliac segment not amenable to or previously unsuccessfully treated by endovascular approach.

Exclusion Criteria:

• Unsuitable for surgery due to general health status

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic vs open Ygraft; Patients with advanced atherosclerosis in aorto iliac segment operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared on the basis of the operative procedure for the primary endpoint, composite endpoint (all-cause mortality, systemic morbidity and graft thrombosis).	Procedure: Laparoscopic vs open Ygraft; Patients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity)	Composite endpoint defined as all-cause mortality, systemic morbidity and graft thrombosis. In this prospective comparative cohort study 50 consecutive patients with type D atherosclerotic lesions in the aortoiliac segment were treated with laparoscopic aortobifemoral bypass operation. The group was compared with 30 patients operated with open aortobifemoral bypass operations for the same disease and period of time. The groups were compared on the basis of composite endpoint All-cause mortality, graft occlusion and systemic morbidity). Stratification analysis was performed by using Mantel-Haenszel method with the patient time model. Cox multivariate regression method was used to adjust for confounding effect after considering the proportional hazard assumption. Cox proportional cause-specific hazard regression model was used for competing risk endpoints. Comparison of survival curves was done with the help of log- rank test.	2005-2015

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time, operative bleeding, length of hospital stay, quality of life	Linear regression model was used to control for the confounding effect of the secondary continuous outcomes.	2005-2015

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Sorlandet Hospital HF; Sykehuset Ostfold

Publications and helpful links

General Publications

• Kazmi SS, Jorgensen JJ, Sundhagen JO, Krog AH, Florenes TL, Kolleros D, Abdelnoor M. A comparative cohort study of totally laparoscopic and open aortobifemoral bypass for the treatment of advanced atherosclerosis. Vasc Health Risk Manag. 2015 Sep 18;11:541-7. doi: 10.2147/VHRM.S92671. eCollection 2015.
• Kazmi SS, Krog AH, Berge ST, Sundhagen JO, Sahba M, Falk RS. Patient-perceived health-related quality of life before and after laparoscopic aortobifemoral bypass. Vasc Health Risk Manag. 2017 May 12;13:169-176. doi: 10.2147/VHRM.S134669. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimated): December 14, 2010

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopic aortic surgery; aorto-iliac occlusive disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Aortic Diseases; Leriche Syndrome
• Other Study ID Numbers: 2010/1953-4