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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 35  |  Issue : 3  |  Page : 442-446

A randomized study comparing conventional surgery versus endovenous laser therapy for the treatment of primary varicose veins of the long saphenous vein


Department of General Surgery, Faculty of Medicine, Benha University, Benha, Egypt

Date of Submission21-Jun-2018
Date of Acceptance08-Oct-2018
Date of Web Publication07-Jan-2019

Correspondence Address:
Dr. Bishoy E Luiz
14-Ebied Street, Qena
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/bmfj.bmfj_126_18

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  Abstract 


Introduction Traditionally, long saphenous vein (LSV) varicosis with saphenofemoral junction incompetence was treated with high ligation and stripping. Postoperatively patients have significant discomfort and bruising. Endovenous laser therapy (EVLT) was developed to offer patients who have varicose veins a less painful treatment alternative to stripping, with a faster return to work and normal activities. EVLT of the LSV has been proven to be safe, with long-term results comparable to traditional high ligation and stripping.
Aim The aim of this work was to compare between two different modalities for the treatment of primary varicose veins disease of the LSV: standard ligation with stripping, and EVLT, with regard to the effectiveness, complications of each treatment modality, recovery and return to work.
Patients and methods This randomized study was conducted upon 40 patients in Benha University Hospital, enrolled from April 2016 to December 2016. Twenty patients underwent high ligation and stripping of LSV, while 20 others underwent EVLT.
Results Our study found no significant difference in success of obliterating the vein using either method; however, patients who underwent EVLT showed less early complications and faster recovery and earlier return to work.
Conclusions EVLT in varicose veins of the LSV is a safe viable alternative to high ligation and stripping using surgery. It has the advantage over surgery of having no incisions, less initial serious complications and faster ambulation and return to work.

Keywords: endovenous laser, varicose vein, vein stripping


How to cite this article:
Ezzat AS, Salem AA, El-Gohary HG, Luiz BE. A randomized study comparing conventional surgery versus endovenous laser therapy for the treatment of primary varicose veins of the long saphenous vein. Benha Med J 2018;35:442-6

How to cite this URL:
Ezzat AS, Salem AA, El-Gohary HG, Luiz BE. A randomized study comparing conventional surgery versus endovenous laser therapy for the treatment of primary varicose veins of the long saphenous vein. Benha Med J [serial online] 2018 [cited 2019 Dec 15];35:442-6. Available from: http://www.bmfj.eg.net/text.asp?2018/35/3/442/249410




  Introduction Top


Varicose veins are dilated, tortuous or lengthened veins, and can be classified as trunk, reticular or telangectasia. Most varicose veins are primary; only the minority of cases are secondary. In varicose veins, the vein wall is inherently weak, which causes dilatation and widening of the cusps of the valves, leading to reflux. Risk factors include increased age, female gender, increased parity, family history, obesity, and prolonged standing [1].

The incompetence of the saphenofemoral junction (SFJ) is the most common cause of varicose veins; however, the short saphenous vein has valvular insufficiency in up to 20% of the affected limbs [2].

Until the past decade, long saphenous vein (LSV) varicosis with SFJ incompetence was most commonly treated with high ligation and stripping. Although an effective treatment, surgical ligation and stripping require general or spinal anesthesia. Postoperatively patients often have significant discomfort and bruising and routinely require analgesia. A desire to offer patients who have varicose veins a less painful treatment alternative to stripping, with a faster return to work and normal activities, led to the development of endovenous thermal ablation techniques [3].

Endovenous laser therapy (EVLT) of the LSV has been proven to be safe, with long-term results comparable to traditional high ligation and stripping. This method offers significantly decreased pain and bruising compared with stripping, with an earlier return to normal activities [3].


  Patients and methods Top


Ethical approval for the study was obtained from the Research Ethics Committee of the Faculty of Medicine, Benha University.

This was a prospective randomized study (by sealed envelope method) that was conducted upon 40 patients in Benha University Hospital. Twenty patients underwent surgery, while 20 others underwent EVLT. All patients were aged above 18 years. Twenty-six of them were male individuals, while 14 were female individuals. All patients had symptomatic varicose veins and primary SFJ incompetence. All patients underwent duplex ultrasonography as part of their initial outpatient assessment. None of the patients had any previous procedure for the treatment of varicose veins in the studied limb. Patients unsuitable for surgery (comorbidities preventing spinal anesthesia) or EVLT (twisting or tortuous LSV) were excluded from the study. Informed consents were obtained from all patients.

Procedures

General description

All cases were treated in the operation room under complete aseptic technique. All cases were operated upon under spinal or general anesthesia.

Surgery

The surgery was carried out with the patient in the supine position, with slight knee flexion and external rotation; an inguinal crease incision is made, just medial to the femoral artery pulse, followed by dissection and ligation of the SFJ, ligation of tributaries, passing the stripper until it reached just below the knee, and, finally, the stripping was carried out. Direct attack phlebectomies were used on veins off the course of LSV, followed by elastic bandage application.

Endovenous laser therapy

The EVLT procedure was carried out with the patient in the supine position, with slight knee flexion and external rotation; tumescent anesthesia using a mixture of 500 ml of cold saline, 10 ml of sodium bicarbonate (1 mmol/ml), 50 ml lidocaine 1%, 0.5 ml adrenaline 1% was injected in the perivenous fascia. This was followed by ultrasound-guided puncture of the LSV below the knee with an 18 G insertion needle. If failed, open venotomy was carried out. Needle introduction is followed by the guide wire and the introduction of a six French sheath. The laser catheter is inserted (600-μm ELVeS Radial laser fiber by Biolitec, Vienna, Austria) and ablation of the vein (1470 nm wave length diode LASER) with manual retraction of the catheter all through the vein is carried out. All steps are performed under ultrasound guidance. Direct attack phlebectomies are used on veins off the course of LSV, followed by elastic bandage application.


  Results Top


The primary end point for the entire study was obliterated or absent signal in LSV by Doppler ultrasound, while the secondary end points were complications and return to normal activity.

Follow-up on regular visits weekly for the first month, every 2 weeks for the next 3 months, and monthly for the remaining 8 months, was completed at 12 months postoperatively. Delayed follow-up findings were registered at 3, 6, and 12 months. All patients showed no Doppler signals in LSV postoperatively.
  1. Immediate follow-up for early complications such as bleeding and pain ([Table 1], [Figure 1]): it is seen from the previous table that there is no significant difference between both groups with regard to the ecchymosis, although in the EVLT group it was mostly related to phlebectomies, not to the ablation site. Primary bleeding and hematoma formation is more common with patients undergoing open surgery, although it occurred in one EVLT patient in whom the percutaneous puncture failed and the vein was reached by open venotomy. Mild skin burn is reserved for patients undergoing EVLT due to the nature of the procedure. The pain was more common in the patients who underwent surgery and was mostly related to the incision site. Surgical site infection affected one patient from the surgery group.
  2. Patients’ ambulation and return to work ([Table 2], [Figure 2]): both groups were encouraged to ambulate as soon as they could. It was noticed that the EVLT group patients were faster to achieve ambulation, and returned to work at a faster rate than patients who underwent surgery.
  3. Three, six and twelve months follow-up ([Table 3], [Figure 3]): at 3 months, one patient of the EVLT group showed recanalization of the LSV. At 6 months, no new recanalization occurred. At 12 months, another patient from the EVLT group showed partial recanalization of the LSV, while one patient from the surgical group showed new thigh varicosities off the course of LSV.
Table 1 Early complications

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Figure 1 Early follow-up.

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Table 2 Patients’ ambulation and return to work

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Figure 2 Patients’ ambulation and return to work.

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Table 3 Recanalization/angiogenesis of long saphenous vein on follow-up

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Figure 3 Recanalization/angiogenesis of long saphenous vein on follow-up

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  Discussion Top


Endovenous laser ablation has been established as a less invasive alternative treatment to saphenous vein stripping and has become popular among vein surgeons. A number of case series and nonrandomized trials have been published, demonstrating the safety and efficacy of this treatment. Results after follow-up are available and show acceptable recurrence and recanalization rates.

Biemans and colleagues published the results of a randomized controlled trial comparing treatments of varicose veins in 2013; patients with a symptomatic primary incompetent LSV at least above the knee with a diameter of greater than or equal to 0.5 cm and with an incompetent SFJ were eligible to participate. In this study, only the LSV in the thigh (from just below or above knee level in most cases) was treated. Patients were randomly allocated to one of the treatments. The primary outcome was anatomic success according to duplex ultrasound evaluation. For EVLT, this was defined as complete obliteration, without flow or reflux, of the LSV at the level of the midthigh. For surgery, success was defined as the absence of the LSV in the saphenous compartment at the thigh level. Secondary outcomes were the type and frequency of complications of the different treatments. In anatomic success, EVLT and surgery were comparably effective (88.5 and 88.2%, respectively), after 1-year follow-up. However, in the surgery group, 10% of patients had neovascularization at ultrasound examination of the groin. This finding was supported by our study, as the success rate was not significantly different, and 5% of the surgery patients had neovascularization at 1-year follow-up. The frequency of adverse events was low and not significantly different between the treatment groups (this contradicts our findings, as pain was significantly higher for the surgery group, while skin burn and thrombophlebitis were significantly higher for the EVLT group); three patients received antibiotics because of wound infection in the groin after surgery; there were no wound infections after EVLT [4], and this complication was confirmed by our study, as one patient from the surgery group suffered from groin infection, while no such occurrence was recorded in the EVLT group.

Rasmussen et al. [5] conducted a randomized controlled study comparing EVLT and stripping whose results were published in 2013 after a 5-year follow-up. The primary end point was open refluxing LSV, while secondary end points were recurrent varicose veins and frequency of reoperations. A total of 121 consecutive patients (137 legs) were randomized to surgery or EVLT. More patients in the EVLT group showed open refluxing segments of more than 5 cm of the treated LSV compared with patients treated with stripping during the 5-year follow-up. The difference was not statistically significant, and this was confirmed by our study with two cases of recanalization in the EVLT group versus. none in the surgical group. However, they found that in the short term, recanalization of the LSV after EVLT seems to have no importance and was not associated with increased clinical recurrence. They found that the clinical recurrence rate of varicose veins was high in both groups with no difference between the groups. We failed to confirm this finding perhaps due to our shorter follow-up period (1-year) versus theirs (5-year). The pattern of reflux in the legs, which developed recurrent varicose veins in their study, was not significantly different between the groups, unlike our study, wherein neovascularization occurred exclusively with one patient of the surgery group. There was no difference between the groups as regards the number of reoperations for recurrent varicose veins. Both treatments significantly improved the symptoms clinically, with no significant differences in the outcomes between the groups, and this was confirmed by our study. The improvements persisted throughout the 5 years and show that both surgery and EVLT are efficient treatments with long-term beneficial effects in patients with LSV varicose veins [5].

Brittenden et al. [6] conducted a large randomized controlled trial in 2015 comparing different treatments of varicose veins. Five hundred and four patients were randomized to EVLT or surgery. The primary outcome measure was disease-specific score, while among their secondary outcome measures were residual varicose veins, complication rates, return to normal activity and truncal vein ablation rates. They found that there were no statistical differences in the disease-specific score between surgery and EVLT at 6 weeks and 6 months. The presence of residual varicose veins, as assessed by the participant and the research nurse, show an apparent improvement (reduction in score) in all groups from baseline to 6 weeks and from 6 weeks to 6 months. They found that there were significantly fewer residual varicose veins following surgery than following EVLT, as assessed by the nurse at 6 weeks, but not at 6 months [6].

They also found that patient-reported pain was significantly higher for EVLT than for surgery, which is not the case with our study, as the pain was higher in the surgical group. They found that there were no differences in ablation success between surgery and EVLT. Their rate for early complication was significantly higher for surgery. The rates for persistent bruising, persistent tenderness and lumpiness at 6 weeks were all significantly higher for those who underwent surgery than for those who underwent EVLT [6].

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
London NJM, Nash R. ABC of arterial and venous disease. BMJ 2000; 320:1391–1394  Back to cited text no. 1
    
2.
Engelhorn C, Engelhorn A, Cassou M, Salles-Cunha S. Patterns of saphenous reflux in women with varicose veins. J Vasc Surg 2005; 41:645–651.  Back to cited text no. 2
    
3.
Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reflux: long-term results. J Vasc Interv Radiol 2003; 14:991–996.  Back to cited text no. 3
    
4.
Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P. et al... Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg 2013; 58:727–734.  Back to cited text no. 4
    
5.
Rasmussen L, Lawaetz M, Bjoern L, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years. J Vasc Surg 2013; 58:421–426.  Back to cited text no. 5
    
6.
Brittenden J, Cotton S, Elders A, Tassie E, Scotland G, Ramsay C et al. Clinical and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the CLASS trial. Health Technol Assess 2015; 19:1–342.  Back to cited text no. 6
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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