The purpose of this study is to compare the complications and outcome of aortic reconstruction in patients with aortoiliac occlusive disease with one of the aortoiliac or aortofemoral bypass surgery methods. 118 patients with lower limb ischemia symptoms in whom aortoilliac occlusion was confirmed before surgery and were candidate for open aortoillac reconstructive surgery were included in the study. Patients who suffered femoral or external iliac obstruction in addition to aortolliac occlusion were excluded.
One of the surgical procedures –aortofemoral or aortoiliac- is randomly selected for patient. Post-operation follow ups are carried out after 3, 6 and 12 months and surgical complications, graft behavior and the necessity for re-operation is evaluated. Finally, the collected data is statistically analyzed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106196832N1
Registration date:2012-04-08, 1391/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-08, 1391/01/20
Registrant information
Name
Hosein Taheri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1853 5211
Email address
taherih881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2011-08-06, 1390/05/15
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of Complications and Outcome of Aortoiliac and Aortofemoral Bypass in the Treatment of Patients with Aortoiliac occlusive Disease
Public title
A Comparison of Aortoiliac and Aortofemoral Bypass in the Treatment of Aortoiliac Occlusive Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with lower limb ischemia who have aortoiliac stenosis or obstruction disease and are candidate for aortiiliac reconstruction.
Exclusion criteria:
Patients who suffer from external iliac or femoral artery obstruction in addition to aortoiliac stenosis. Patients who couldn’t continue or wish to discontinue their participation in the study due to any reason.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research of Mashhad University of Medical Sciences