Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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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

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Aorto Iliac Occlusive Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Laparoscopic vs open Ygraft

Intervention Type PROCEDURE

Patients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared.

Interventions

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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.

Intervention Type PROCEDURE