No registrations found.
ID
Source
Brief title
Health condition
Recurrence of varicosis.
Endovenous laser technique versus stripping
Local anaesthesia
Treatment of the long saphenous vein incompetence
Sponsors and support
Koninginneweg 9
1217 KP Hilversum
Koninginneweg 9
1217 KP Hilversum
Intervention
Outcome measures
Primary outcome
Primary endpoint is the recurrence rate of the varicose vein.
Secondary outcome
Secondary endpoints are complicatons and quality of life.
Background summary
Early veins are relatively benign, but some patients will progress to develop severe and irreversible problems of chronic venous insufficiency, including venous ulcers. Surgery, by high ligation and stripping of thrunk veins, is still considered the "gold standard" for treatment of varicose veins in association with trunk incompetence.
Recently, the endovenous laser treament is introduced. The promissing treatment reports less recurrences. complications and a better quality of life. In this study we will compare the postoperative results of endovenous laser treatment with the traditional stripping procedure, performed under local anaesthesia.
Study objective
The recurrence risk after endovenous laser treatment is less than after stripping of the long saphenous vein performed under local anaesthesia.
Study design
Recurrence of varicose vein can be diagnosed from 6 month till several years after operations. Interim analyse will be done from 1 year till 10 years after the operation.
Intervention
- Stripping method
- Endovenous laser therapy
Inclusion criteria
1. Long saphenous vein (LSV) incompetence (duplex: reflux > 0,5 sec. measured and seen in standing position by manual compression or valsalva manouvre)
2. Diameter of LSV equal or more than 0,3 cm and equal or less than 1,5 cm
3. Length of LSV traject more than 15 cm intrafascial
4. No earlier operations
5. Age between 18-70 years
6. CEAP classification equal or more than C2
7. Informed consent
Exclusion criteria
1. Patient does not meet the therefore mentioned inclusion criteria
2. Pregnancy
3. Immobility
4. Pathology deep venous system
5. Patients don't wish to be operated under local anaesthesia
6. Proven reaction on lidocaine
7. Contra indications to stop Clopidogrel or coumarine or that can not be stopped or temporarely replaced by fraxiparine
8. Flebitis in time of surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1198 |
| NTR-old | NTR1243 |
| Other | : 12256.049.07 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
<br><br>
Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results.<br>
Pronk P, Gauw SA, Mooij MC, Gaastra MT, Lawson JA, van Goethem AR, van Vlijmen-van Keulen CJ.
<br><br>
Flebologisch Centrum Oosterwal, Overkrocht 10, 1815 KX Alkmaar, The Netherlands. pascalpronk888@hotmail.com. <br><br>
Stefanie A. Gauw, CRC, James A. Lawson, MD, PhD, Clarissa J. van Vlijmen-van Keulen, MD, PhD,
Pascal Pronk, MD, Menno T. W. Gaastra, MD, and Michael C. Mooij, MD. Five-year follow-up of a randomized, controlled
trial comparing saphenofemoral ligation and
stripping of the great saphenous vein with
endovenous laser ablation (980 nm) using local
tumescent anesthesia. Journal of vascular surgery. February 2016. Volume 63, Number 2: 420-428