Laparoscopic Surgical Treatment of Abdominal Aortic Aneurysms and Aorto-iliac Occlusive Disease (LAS)

This study is currently recruiting participants.
Verified September 2010 by Oslo University Hospital
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01259908
First received: December 13, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

Patients with abdominal aortic aneurysms with an anterioposterior or transverse diameter of 55 mm or greater and also patients with an aorto-iliac occlusive disease (Type TASC-D) will be offered a totally laparoscopic operation.


Condition
Abdominal Aortic Aneurysm
Aorto-iliac Occlusive Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • No residual symptoms of claudication intermittent among patients with aorto-iliac occlusive disease and no residual or recurrent aneurysm among patients operated for AAA one year post-operatively [ Time Frame: 2011-2020 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality per- and post-operatively [ Time Frame: 2011-2020 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Patients with abdominal aortic aneurysms with an anterioposterior or transverse diameter of atleast 55 mm and also patients with an aorto-iliac occlusive disease (Type TASC-D) will be offered a totally laparoscopic operation.

Patients operated with conventional open surgery shall be included as a control group.

Operative data and post-operative outcomes (Morbidity and mortality, etc)shall be registered prospectively. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with infra-renal abdominal aortic aneurysm (AAA) with a size 55mm or greater.

Patients with aorto-iliac occlusive disease (Type D lesion according to the Trans Attlantic intersociety Consensus TASC II)

Criteria

Inclusion Criteria:

  • All patients with an infra renal AAA 55mm or greater. 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
  • Concomittent cancers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259908

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Syed Sajid Hussain Kazmi, MD    +47 22894000    s.s.h.kazmi@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Syed Sajid Hussain Kazmi, 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: December 13, 2010
Health Authority: Norway: Regional Ethics Committee

Keywords provided by Oslo University Hospital:
laparoscopic aortic surgery
aorto-iliac occlusive disease
abdominal aortic aneurysm
Abdominal aortic aneurysm and aorto-iliac occlusive disease

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

ClinicalTrials.gov processed this record on April 22, 2014