study will be in shohayae-tajrish hospital.the duration of study will be 18 mounts and patients will be follow up for 18 months.all patients with inclusion criteria after initial physical exams will enter to 2 groups (laser group or open surgery) 65 patients ELVT group and 35HLS group are going to treat with a 980-nm laser diode under local anesthesia. CEAP classification (Clinical Severity, Etiology, Anatomy, Pathophysiology) and AVSS scores (Aberdeen Varicose Vein Symptom Severity Score) are used to determine disease severity and symptoms before and after the procedure. Outcome will be measure by the rate of recurrence as will be show in Doppler ultrasonography evaluation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301118146N5
Registration date:2013-01-26, 1391/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-26, 1391/11/07
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and side effects of Endovenous laser treatment for uncomplicated varicose veins: a randomized comparative study
Public title
Efficacy of laser in varicose insufficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 65 years; insufficiency of GSV and the Saphenofemoral junction (SFJ) with reflux at least up to the knee and symptoms of GSV insufficiency or CVI.
Exclusion criteria: pregnancy; active malignancy; arterial occlusive disease with an Ankle Brachial Index of below 0.8; acute deep vein thrombosis (DVT); thrombophilia or high risk of pulmonary thromboemboli; history of inguinal surgery except for hernia and insufficiency of the lesser saphenous vein in the same limb requiring treatment.
aim :compare Efficacy and side effects of Endovenous laser treatment for uncomplicated varicose vein
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
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
shahid beheshti ethics committee
Street address
shahid beheshti medical university
City
tehran
Postal code
Approval date
2009-06-21, 1388/03/31
Ethics committee reference number
69
Health conditions studied
1
Description of health condition studied
Varicose veins of lower extremities
ICD-10 code
183
ICD-10 code description
183.9
Primary outcomes
1
Description
patency rate
Timepoint
6months-12 month- 18 month
Method of measurement
Doppler Ultrasonography
2
Description
CEAP score
Timepoint
before treatment- 3 week-6 month-12 month-18 month
Method of measurement
physical exam
3
Description
AVVSS score
Timepoint
Before treatment -1week 3 month-6 month-12 month-18 month
Method of measurement
physical exam
Secondary outcomes
1
Description
pain
Timepoint
before treatment-1 week-3 month-6 month-12 month-18 month
Method of measurement
physical exam
2
Description
edema
Timepoint
before treatment--1 week-3 month-6 month-12 month-18 month