Cryo strip versus classic strip of the great saphenous vein
| ISRCTN | ISRCTN61851091 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61851091 |
| Secondary identifying numbers | NL902 (NTR926) |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 22/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr T M A L Klem
Scientific
Scientific
Berglustlaan 44a
Rotterdam
3054 BJ
Netherlands
| t.klem@wxs.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Cryo strip versus classic strip of the great saphenous vein |
| Study objectives | Recurrence rate of cryo strip is the same as classic strip of the great saphenous vein. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Venous surgery |
| Intervention | Cryo strip of the great saphenous vein versus classic strip of the great saphenous vein. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Recurrence, confirmed by venous duplex. |
| Secondary outcome measures | 1. Operation time 2. Neurological damage after surgery 3. Quality of life |
| Overall study start date | 01/08/2002 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 520 |
| Key inclusion criteria | 1. Patients with primary varicosis and incompetence of the great saphenous vein and saphenofemoral junction (confirmed by duplex) 2. Only patients with C2, C3, C4 varicosis (Clinical, Etiologic, Anatomic, and Pathophysiologic [CEAP]-classification) |
| Key exclusion criteria | 1. C5, C6 varicosis 2. Extreme adipositas (Body Mass Index [BMI] greater than 40) 3. Deep venous occlusion 4. Incompetence of the small saphenous vein 5. Arterial occlusive disease of the legs 6. Inability to understand the Dutch language 7. Recurrence of varicosis of the leg |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Berglustlaan 44a
Rotterdam
3054 BJ
Netherlands
3054 BJ
Netherlands
Sponsor information
Saint Franciscus Hospital (Sint Franciscus Gasthuis [SFG]) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Kleiweg 500
Rotterdam
3045 PM
Netherlands
| Website | http://www.sfg.nl/ |
|---|---|
"ROR" |
https://ror.org/007xmz366 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (The Netherlands)
No information available
Albert Schweitzer Ziekenhuis (The Netherlands)
No information available
Sint Franciscus Gasthuis (SFG) (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 |
Editorial Notes
22/09/2021: Proactive update review. No publications found. Search options exhausted.
