Comparison of Treatments in Venous Insufficiency

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01298908
• Collaborator: (none)
• Enrollment: 231
• Locations: 2
• Arms: 3
• Duration (Months): 98
• Patients Per Site: 115.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.

Condition or Disease	Intervention/Treatment	Phase
Venous Insufficiency	Procedure: Operative treatment; Procedure: Laser ablation; Procedure: Foam sclerotherapy	N/A

Detailed Description

In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.

Study Design

• Study Type: Interventional
• Actual Enrollment: 231 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Operative treatment vein stripping	Procedure: Operative treatment; In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.; Other Names: Vein stripping
Other: Laser ablation Ultrasound guided laser ablation	Procedure: Laser ablation; In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.; Other Names: Ultrasound guided laser ablation
Other: Foam sclerotherapy Ultrasound guided foam sclerotherapy	Procedure: Foam sclerotherapy; Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.; Other Names: Ultrasound guided foam sclerotherapy

Outcome Measures

Primary Outcome Measures

1. Recanalization or reflux of the treated venous trunk [at 1 and 12 months]

   Results will be verified by Duplex scanning

Secondary Outcome Measures

1. Symptom relief [at 1 and 12 months]

   Symptoms will be evaluated by using CEAP-classification and degree of disability

2. Complications related to procedure [at 1 and 12 months]

   At 1 month follow-up immediate complications will be recorded. At 12 months follow-up appearance of late complications and pain and incapacity for work due to the procedure will be recorded.

3. Quality of life [at 1 and 12 months]

   Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with chronic superficial vein insufficiency

• patient must be 20-70 years old

• degree of difficulty of vein insufficiency C2-C4

• average diameter of refluxing great saphenous vein 4 -10 mm

• patient is agreeable to the study

Exclusion Criteria:

• peripheral atherosclerotic occlusive disease

• lymphoedema

• severe concomitant disease

• venous ulcers or unclassified skin changes

• BMI more than 40

• pregnancy

• allergy to the foam used in sclerotherapy or to local anaesthetics

• coagulation disorder

• bilateral vein insufficiency (equal symptoms)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Vascular Surgery, Helsinki University Central Hospital	Helsinki	HUS	Finland	00029
2	Department of Vascular Surgery, Tampere University Hospital	Tampere		Finland	33521

Sponsors and Collaborators

• Helsinki University Central Hospital

Investigators

• Study Director: Maarit Venermo, MD,PhD, Department of Vascular Surgery, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maarit Venermo, MD, PhD, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT01298908
• Other Study ID Numbers: Version 1.0 - Sep 6th, 2006
• First Posted: Feb 18, 2011
• Last Update Posted: Jan 8, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Maarit Venermo, MD, PhD, Helsinki University Central Hospital: varicose veins, oedema
• Additional relevant MeSH terms: Venous Insufficiency

Study Results

No Results Posted as of Jan 8, 2016