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

18 Jul 2008

The date of last modification

Jan 30, 2019


Trial Status



Application Summary


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)


Trial Details


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)

  1. Occlusion of long saphenous vein

    []

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

    []

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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Faculty of Medicine





Secondary study sponsor (If any)

None





Trial Completion details


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