Randomised clinical trial comparing endovenous laser ablation with cryostripping for varicose veins: two-year results
| ISRCTN | ISRCTN33832691 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33832691 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/03/2008
- Registration date
- 31/03/2008
- Last edited
- 24/02/2009
- 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 | Study questions: 1. Is endovenous laser of the great saphenous vein clinically better than cryostripping? 2. Is endovenous laser of the great saphenous vein less expensive than cryostripping? |
| Ethics approval(s) | Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre on the 15th March 2003. |
| Health condition(s) or problem(s) studied | Varicose veins |
| Intervention | Endovenous laser versus cryostripping. |
| Intervention type | Other |
| Primary outcome measure | The following were assessed at 6, 12 and 24 months: 1. Freedom from recurrence 2. Improvement in Venous Clinical Severity Score (VCSS) 3. Improvement in Aberdeen Varicose Vein Severity Score (AVVSS) 4. Improvement in the short form 6D (SF-6D), a single preference based measure of health, representing overall quality of life derived from the 36-item short form 36 (SF-36) questionnaires |
| Secondary outcome measures | The following were assessed at 6, 12 and 24 months: 1. Operative time 2. Complications 3. Activity impairment 4. Quality-adjusted life years (QALY) 4. Patient satisfaction |
| Overall study start date | 01/06/2003 |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Patients with primary symptomatic varicose veins 2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease 3. Informed written consent 4. Age 19 - 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 ultrasound imaging |
| Key exclusion criteria | 1. Previous venous surgery 2. History of deep vein thrombosis (DVT) 3. C3-6 CEAP 4. Deep vein reflux 5. Anatomical duplication 6. Reflux in below-knee perforator veins |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/07/2005 |
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 Utrecht) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr Ben Disselhoff
Van Heuven Goedhartlaan 1
CE Utrecht
3527
Netherlands
| Website | http://www.mesos.nl |
|---|
Funders
Funder type
Hospital/treatment centre
The Mesos Medical Centre (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 | 01/10/2008 | Yes | No | |
| Other publications | reuslts on cost-effectiveness | 01/03/2009 | Yes | No |
