Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
Sykehuset Ostfold
Sorlandet Hospital HF
Information provided by (Responsible Party):
Syed Sajid Hussain Kazmi, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01259908
First received: December 13, 2010
Last updated: September 23, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Aorto Iliac Occlusive Disease
Procedure: Laparoscopic vs open Ygraft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laparoscopic Aortic Surgery: Norwegian Experiance

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity) [ Time Frame: 2005-2015 ] [ Designated as safety issue: No ]

    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:
  • Operative time, operative bleeding, length of hospital stay, quality of life [ Time Frame: 2005-2015 ] [ Designated as safety issue: No ]
    Linear regression model was used to control for the confounding effect of the secondary continuous outcomes.


Enrollment: 80
Study Start Date: September 2010
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259908

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Sykehuset Ostfold
Sorlandet Hospital HF
  More Information

Publications:
Responsible Party: Syed Sajid Hussain Kazmi, Consultant Surgeon, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01259908     History of Changes
Other Study ID Numbers: 2010/1953-4 
Study First Received: December 13, 2010
Last Updated: September 23, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
laparoscopic aortic surgery
aorto-iliac occlusive disease

Additional relevant MeSH terms:
Leriche Syndrome
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on December 09, 2016