Cryo strip versus classic strip of the great saphenous vein
| ISRCTN | ISRCTN61851091 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61851091 |
| Protocol serial number | NL902 (NTR926) |
| Sponsor | Saint Franciscus Hospital (Sint Franciscus Gasthuis [SFG]) (The Netherlands) |
| Funders | Erasmus Medical Centre (The Netherlands), Albert Schweitzer Ziekenhuis (The Netherlands), Sint Franciscus Gasthuis (SFG) (The Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Recurrence, confirmed by venous duplex. |
| Key secondary outcome measure(s) |
1. Operation time |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
22/09/2021: Proactive update review. No publications found. Search options exhausted.
