| Scientific Title of Trial | Sclerotherapy to the long saphenous vein-a less invasive alternative | |
| Public Title of Trial (in lay language) | Sclerotherapy to the long saphenous vein in patients with varicose veins | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | Varicose Veins | |
| 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 ? | |
| Study design | Prospective randomised controlled study | |
| 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 | |
| Target number / sample size | 300 | |
| Primary outcome(s) | Occlusion of long saphenous vein | |
| Primary outcome(s) - time of assessment(s) | ||
| Secondary outcome(s) | •Post operative pain •Time to discharge after the procedure •Time to return to daily activities •Post operative complications like wound infection, DVT | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/10/2006 | |
| Anticipated end date | 01/10/2009 | |
| Recruitment status | Current | |
| State of ethics review approval | Approved by the Ethical Review Committee of Faculty of Medicine, Colombo |
|
| Funding source(s) | None | |
| Applicant's Email | mandika59@hotmail.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Mandika Wijeyaratne
Head of the Department, Department of Surgery, Faculty of Medicine, Colombo No11, Esther Avenue, Park Road, Colombo 05 0777344482 mandika59@hotmail.com |
|
| Primary Study Sponsor/ Organization | Faculty of Medicine
|
|
| Contact Person for Public Queries | Mandika Wijeyaratne Head of the Department, Department of Surgery, Faculty of Medicine, Colombo No11, Esther Avenue, Park Road, Colombo 05. 0777344482 mandika59@hotmail.com |
|
| Secondary Study Sponsor(s), (if any) | None |
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