Home » Trials » SLCTR/2008/014
Sclerotherapy to the long saphenous vein-a less invasive alternative
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SLCTR Registration Number
SLCTR/2008/014
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Sclerotherapy to the long saphenous vein-a less invasive alternative
Public Title of Trial
Sclerotherapy to the long saphenous vein in patients with varicose veins
Disease or Health Condition(s) Studied
Varicose Veins
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/03/066 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Using sclerosant foam (4ml of 4% sodium tetradecyl sulphate, 4ml of distilled water and 4ml of ambient air forcibly mixed under pressure) therapy in the treatment of vericose veins due to sapheno femoral incompetence and long saphenous vein incompetence ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Using sclerosant foam therapy as a standard treatment method in patients with varicose veins due to sapheno femoral incompetence and long saphenous vein Incompetence
Inclusion criteria
Patients with varicose veins due to sapheno femoral incompetence and long saphenous vein incompetence Patients who had given the consent
Exclusion criteria
Proven secondary varicose veins due to deep vein thrombosis, arterio venous fistulae or pregnancy Recurrent sapheno femoral incompetence after previous sapheno femoral ligation Significant below knee varicosities outside the long saphenous Vein territory which would require stab avulsions Patients with active venous ulcers Patients with documented allergy to sclerosant
Primary outcome(s)
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1.
Occlusion of long saphenous vein |
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Secondary outcome(s)
|
1.
•Post operative pain •Time to discharge after the procedure •Time to return to daily activities •Post operative complications like wound infection, DVT |
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Target number/sample size
300
Countries of recruitment
Sri Lanka
Anticipated start date
2006-10-01
Anticipated end date
2009-10-01
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2004-07-15
Approval number
EC/03/066
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Mandika Wijeyaratne
Head, Department of Surgery,
Faculty of Medicine, Colombo
No11, Esther Avenue, Park Road, Colombo 05
0777344482
mandika59@hotmail.com
Contact Person for Public Queries
Mandika Wijeyaratne
Head, Department of Surgery,
Faculty of Medicine, Colombo
No11, Esther Avenue, Park Road, Colombo 05
0777344482
mandika59@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
