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

This study is currently recruiting participants. (see Contacts and Locations)
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
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 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 August 27, 2014