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

University of Oslo (UIO)

Status: Completed

Conditions: Aorto Iliac Occlusive Disease

Treatments: Procedure: Laparoscopic vs open Ygraft

Study type: Observational

Funder types: Other

Identifiers

NCT01259908

2010/1953-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

80 participants in 1 patient group

Laparoscopic vs open Ygraft

Description:

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).

Treatment:

Procedure: Laparoscopic vs open Ygraft