Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease

Completed

• Conditions: Aorto Iliac Occlusive Disease
• Interventions: Procedure: Laparoscopic vs open Ygraft

• Registration Number: NCT01259908
• Lead Sponsor: Oslo University Hospital

Brief 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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2023-05
• Study Completion: 2023-05
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

• Unsuitable for surgery due to general health status

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic vs open Ygraft	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).

Primary Outcome Measures

Name	Time	Method
Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity)	2005-2015	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway