Randomised clinical trial comparing endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction, with a two-year follow-up
ISRCTN | ISRCTN60300873 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN60300873 |
Secondary identifying numbers | N/A |
- Submission date
- 14/03/2008
- Registration date
- 31/03/2008
- Last edited
- 11/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Ben Disselhoff
Scientific
Scientific
Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | Is high ligation after endovenous laser ablation better than endovenous laser alone? |
Ethics approval(s) | Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre, Utrecht (The Netherlands) on the 15th March 2003. |
Health condition(s) or problem(s) studied | Varicose veins |
Intervention | Forty-three symptomatic patients with bilateral varicose veins were studied in which one side was randomly assigned to receive endovenous laser without saphenofemoral junction (SFJ) ligation, whereas the other side received endovenous laser with SFJ ligation. |
Intervention type | Other |
Primary outcome measure | Freedom from recurrent varicose veins in the groin, as confirmed by duplex ultrasound, two years after treatment. |
Secondary outcome measures | The following were assessed at 6, 12 and 24 months: 1. Abolition of reflux in the GSV 2. Venous Clinical Severity Score (VCSS) 3. Freedom from overall recurrent varicose veins 4. Procedural complications, including pain, bruising, saphenous nerve paraesthesia, tightness, superficial thrombophlebitis, skin burns, thrombotic events, and wounds |
Overall study start date | 01/03/2003 |
Completion date | 01/04/2005 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 43 |
Key inclusion criteria | 1. Patients with primary symptomatic bilateral varicose veins 2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease 3. Informed written consent 4. Aged 20 - 75 years 5. Great saphenous vein (GSV) incompetence from the groin to below the knee, defined as retrograde flow lasting longer than 0.5 seconds on duplex scanning |
Key exclusion criteria | 1. Previous venous surgery 2. History of deep vein thrombosis (DVT) 3. C3-6 CEAP venous disease 4. Deep vein relux 5. Reflux in below knee perforator veins |
Date of first enrolment | 01/03/2003 |
Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands
1401 BS
Netherlands
Sponsor information
The Mesos Medical Centre (Mesos Medisch Centrum) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr Ben Disselhoff
Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands
Funders
Funder type
Hospital/treatment centre
The Mesos Medical Centre (Mesos Medisch Centrum) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/12/2008 | Yes | No | |
Results article | results | 01/05/2011 | Yes | No |