NCT01298908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

5.2 years

First QC Date

February 17, 2011

Last Update Submit

January 6, 2016

Conditions

Venous Insufficiency

Keywords

varicose veins, oedema

Outcome Measures

Primary Outcomes (1)

  • Recanalization or reflux of the treated venous trunk

    Results will be verified by Duplex scanning

    at 1 and 12 months

Secondary Outcomes (3)

  • Symptom relief

    at 1 and 12 months

  • Complications related to procedure

    at 1 and 12 months

  • Quality of life

    at 1 and 12 months

Study Arms (3)

Operative treatment

OTHER

vein stripping

Procedure: Operative treatment

Laser ablation

OTHER

Ultrasound guided laser ablation

Procedure: Laser ablation

Foam sclerotherapy

OTHER

Ultrasound guided foam sclerotherapy

Procedure: Foam sclerotherapy

Interventions

Operative treatmentPROCEDURE

In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.

Also known as: Vein stripping
Operative treatment
Laser ablationPROCEDURE

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.

Also known as: Ultrasound guided laser ablation
Laser ablation
Foam sclerotherapyPROCEDURE

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.

Also known as: Ultrasound guided foam sclerotherapy
Foam sclerotherapy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Vascular Surgery, Helsinki University Central Hospital

Helsinki, HUS, 00029, Finland

Location

Department of Vascular Surgery, Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

  • Vahaaho S, Halmesmaki K, Alback A, Saarinen E, Venermo M. Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. Br J Surg. 2018 May;105(6):686-691. doi: 10.1002/bjs.10757.

    PMID: 29652086DERIVED

MeSH Terms

Conditions

Venous InsufficiencyVaricose VeinsEdema

Interventions

Laser TherapyTransurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, OperativeProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Maarit Venermo, MD,PhD

    Department of Vascular Surgery, Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

October 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

FI(2)