NCT01259908

Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease

Laparoscopic Aortic Surgery: Norwegian Experiance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Aorto Iliac Occlusive Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2010-12-14
• Last updated: 2023-06-22

Locations

1 site across 1 country: Norway