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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 28
| Issue : 2 | Page : 149-153 |
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Quality of life in patients undergoing endovenous laser ablation and saphenofemoral ligation and stripping
Deepesh D Madhu1, MT Saji2, PK Manilal2
1 ESI Dispensary, Alappuzha, Kerala, India
2 Department of General Surgery, Holy Cross Hospital, Kollam, Kerala, India
| Date of Submission | 14-Nov-2022 |
| Date of Decision | 26-Nov-2022 |
| Date of Acceptance | 02-Dec-2022 |
| Date of Web Publication | 30-Jan-2023 |
Correspondence Address:
Dr. Deepesh D Madhu
Insurance Medical Officer, ESI Dispensary, Pathirappally, Alappuzha - 688 521, Kerala
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/ksj.ksj_38_22
Introduction: Surgery for varicose veins was the treatment of choice before the advent of minimally invasive procedures. Aim: This study was done to compare the utility of endovenous laser ablation (EVLA) as an effective alternative to surgery to treat varicose veins. Materials and Methods: The study was conducted in a tertiary care hospital between October 2019 and March 2021. One hundred and six patients with varicose veins of the long saphenous system were included in the study, 53 in the laser surgery group and 53 in the open surgery group. European Quality of life 5 dimensions questionnaire, the WHO VAS score and clinical aetiological, anatomical and pathological classification for varicose veins scores of the affected limb of the patients were recorded preoperatively and postoperatively at day 90. Data were statistically analysed using SPSS. Results: Patients treated by EVLA enjoyed a better quality of life than the ligation and stripping group. They experience significant reduction in the post-operative pain, the absence of wound infection and a significant reduction in the clinical severity scores. Conclusion: EVLA is a safer and effective means for treating varicose veins.
Keywords: Clinical aetiological, anatomical and pathological, endovenous laser ablation, European quality of life 5 dimensions questionnaire, open surgery, varicose vein, WHO Visual analogue score
How to cite this article:
Madhu DD, Saji M T, Manilal P K. Quality of life in patients undergoing endovenous laser ablation and saphenofemoral ligation and stripping. Kerala Surg J 2022;28:149-53 |
How to cite this URL:
Madhu DD, Saji M T, Manilal P K. Quality of life in patients undergoing endovenous laser ablation and saphenofemoral ligation and stripping. Kerala Surg J [serial online] 2022 [cited 2023 Mar 25];28:149-53. Available from: http://www.keralasurgj.com/text.asp?2022/28/2/149/368595 |
| Introduction | |  |
Varicose veins are dilated tortuous veins more than 3 mm diameter with demonstrable reflux. Varicosities may affect either great saphenous vein (GSV) or short saphenous vein or both.[1] Varicose veins are among the most common surgical problem, in the patients attending surgery outpatient department. Patients may present with dilated veins, aching pains, pigmentation, eczema and ulcers.[2]
Varicose vein disease significantly impairs the quality of life of patients.[3] Surgical treatment was the treatment of choice before the advent of minimally invasive procedures. The complications of open surgery and the fear of an open surgical procedure make the patient reluctant to adopt interventional management. Endovenous laser ablation (EVLA) is a day care procedure and does not require wound care, post-operative rest and the patient can resume his work early. Thus, decreasing post-operative morbidity and improving the post-operative quality of life. So that the patient can return to his job earlier. This along with reduced hospital stay may reduce the financial burden.
Although several foreign studies have assessed the cost-effectiveness, improved quality of life after EVLA, the suitability of adoption of this newer technique in our setting of limited resources remains largely unknown. This study is aimed at throwing light on the efficacy of EVLA, as a less painful, effective alternative in improving the quality of life of varicose vein patients with minimal hospital stay and optimal utilisation of resources.
| Materials and Methods | | |
This prospective observational study attempted to assess the quality of life of patients undergoing EVLA and conventional surgery (saphenofemoral ligation and stripping), to demonstrate EVLA as a safer and effective alternative to conventional surgery, to compare post-operative pain of patients undergoing EVLA and conventional surgery (saphenofemoral ligation and stripping) and to compare the duration of hospital stay of patients undergoing EVLA and conventional surgery (saphenofemoral ligation and stripping).
This was conducted in a tertiary care hospital between October 2019 and March 2021. One hundred and six patients, 53 in the laser surgery group and 53 in the open surgery group undergoing surgical treatment for varicose vein disease were included in the study. Patients above 18 years with symptoms and complications of varicose vein disease, giving consent for the study and willing to do either open surgery (saphenofemoral flush ligation and stripping) or EVLA were included in the study. Patients who did not give consent, those who had deep vein thrombosis and persons with psychiatric illness were excluded from the study. Eligible patients were selected to each group (to the laser and conventional surgery group) using the non-probability sampling technique.
A pre-designed pro forma was used to collect the baseline data. Age, type of occupation, smoking status, alcoholism, diabetes, hypertension, family history, post-operative pain score, duration of hospital stay, clinical severity of varicose vein disease and quality of life were noted. Patients were examined clinically and a duplex scan of the affected limb was taken in addition to the pre-operative investigations before undergoing surgery. They were included either in the laser surgery group or conventional surgery group by non-probability sampling technique. For each patient European Quality of life 5 dimensions (EQ 5D) questionnaire was filled just before the surgery, 1 week and 3 months after the surgery. The WHO VAS score was obtained for each group undergoing open surgery and EVLA on post-operative days (POD) 1, 3 and 7. Clinical aetiological, anatomical and pathological [CEAP] classification for varicose veins scores of the affected limb of the patients in the laser group and conventional surgery group were recorded preoperatively and postoperatively (on POD 90). The EQ 5D questionnaire, WHO VAS score for pain (on PODs 1, 3 and 7), CEAP score (pre-operative and POD 90) and EQ VAS for overall health score (pre-operative and POD 90) were filled by the investigator himself, after interviewing the patient personally or over the phone. Patients were followed up for 3 months and the results were recorded and statistically analysed using standard SPSS software (IBM, Delhi).
| Results | | |
Of the 106 patients, 53 patients were in the laser surgery group and 53 in the conventional open surgery group. Most of the patients belonged to the age group 50–60 years, which accounted for 41.5%. Males constituted 69 (65.1%) and females constituted 37 (34.9%) of the study group. Skilled labourers constituted the majority (39.6%). Twelve persons (11%) in the study group gave a positive family history of varicose vein disease. The study variables of the laser group and open surgery group are detailed in [Table 1]. | Table 1: Comparison of study variables from laser surgery group and open surgery group
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Post-operative pain was measured using the WHO visual analogue scale on PODs 1, 3 and 7. When statistically analysed, there were significant differences between the post-operative pains on day 1, 3 and 7 in both groups, with a lower score in the EVLA group. The pre-operative clinical severity was compared to the post-operative clinical scores of the saphenofemoral ligation and stripping group and showed statistically significant improvement (P < 0.001). The pre-procedural and post-procedural clinical severity scores of the EVLA group also showed statistically significant difference (P < 0.001). Most of the patients belonged to the C4 clinical severity in both groups. C6 which consists of active ulcers was formed by four persons in both groups [Table 2]. | Table 2: Distribution of clinical severity (c) of the clinical aetiological, anatomical and pathological classification
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There was significant difference (P < 0.001) in the post-operative wound infection in the laser surgery group and open surgery group. No individuals in the laser study group had post-operative wound infection as shown in [Table 3].
On studying, the post-operative disease severity as per the CEAP scoring system in the laser surgery group and open surgery group, there was no significant difference between the groups, which means that both open surgery and laser surgery are efficacious in decreasing the disease severity.
Quality of life as measured using EQ 5D questionnaire showed significant difference (P < 0.001) in the quality of life of patients who underwent EVLA and the open surgery. However, analysis showed that there are no significant differences between the two groups on POD 90. The quality of life as expressed using EQ VAS shows significant difference before and after EVLA treatment.
There were significant differences (P < 0.001) in the hospital stay in both open surgery group and laser surgery group. Laser surgery was associated with a shorter duration of hospital stay. The average duration of hospital stay in the laser surgery group was 2.02 days and that in the open surgery was 4.17 days.
| Discussion | | |
Varicose vein disease affects nearly 20% of the Western population but in India, it is around 5%.[4] In Indians, it is usually a neglected disease due to the several socioeconomics reasons such as costume habits of covering legs, aesthetic disregard and the occurrence of the disease among the poor working class who has to stand for a long time and reluctance in seeking medical help. These factors may also contribute to the underreporting of the condition.
Saphenofemoral flush ligation and stripping is the most common surgical treatment done for varicose vein disease. Boersma et al. in their study have shown that the most common complication they came across in open surgical technique involving flush ligation and stripping of the GSV was nerve injury, characterised by paraesthesia.[5]
The effect of the long saphenous vein stripping in the treatment of varicose vein, on health-related quality of life (HRQoL) was assessed by a prospective study conducted in the United Kingdom involving 102 patients by Michaels et al. and the study summarised that long saphenous vein stripping leads to significant improvement in disease-specific HRQoL, for as much as 2 years.[6]
EVLA is a noval technique for the treatment of varicose vein disease. Rathod et al. conducted a study on “The outcomes using a 1470 nm laser for symptomatic varicose veins.” They described EVLA to be a minimally invasive, safe and outpatient procedure. The most common complication they encountered was paraesthesia (10.53%). When they followed up the patients for 1 year, venous occlusion rate and ulcer healing rates were 98.61% and 85%, respectively.[7]
Christenson et al. in their randomised trial, compared closure rate, complication rate, the Aberdeen varicose vein symptom severity score and the varicose venous clinical severity score and concluded that abolition of GSV reflux and improvement in quality of life were similar after conventional surgery and EVLT.[8] Prabakar and Jahangir conclude that EVLA with 1470 nm radial fibre is an acceptable and effective treatment modality for the management of lower limb varices and is associated with no major complications.[9]
In the present study, most of the patients belonged to the age group of 50–60 years, which accounted for 41.5%. Joseph et al. also found that the majority of cases were of the age group 41–50 years.[2]
In our study, 65.1% were males and 34.9% females. Ali et al. found that 70% were males and 30% were females,[10] whereas most of the Western studies show a higher incidence of varicose vein disease in females.[3],[11]
39.6% of persons in the present study were skilled workers. The job of skilled workers demands standing for a long time, like that of semi-skilled and manual labourers. Most of the published literature admits an association of varicose vein disease with jobs requiring prolonged standing.[1],[12] Ali et al. found that 73% of patients in their study had a history of prolonged standing.[10]
Eleven percent of patients of the present study gave a positive history of varicose vein disease among the first-degree relatives. Sharma et al. found that 61.1% of patients had positive family history,[13] whereas Pramod et al. found that 25% of patients had a positive family history.[14]
A visual analogue scale score of 0–10 was applied to measure pain intensity, where 0 indicates no pain and 10 indicates the worst pain. When statistically analysed, post-operative pains on days 1, 3 and 7 showed statistically significant differences in the EVLA group and saphenofemoral ligation and stripping group, with significantly lower pain scores in the EVLA group.
The clinical severity score of the varicose vein disease was calculated using CEAP classification. This score was calculated preoperatively and POD 90 for both the EVLA group and saphenofemoral ligation and stripping groups. In my study, there is a significant difference in pre-operative and post-operative clinical severity indicating a significant reduction in the disease severity following EVLA. Similar results were also obtained in the saphenofemoral ligation and stripping group. Statistical analysis of post-operative clinical severity scores showed no significant difference between the two groups. Hence, it can be interpreted that EVLA is at least as good as saphenofemoral ligation and stripping in reducing the disease severity.
In the group who were treated by EVLA, four patients had active ulcers (clinical severity c6). At the end of 90 days, the ulcer got healed in all four patients. While in the saphenofemoral ligation and stripping group, four patients had an active ulcer (clinical severity c6) preoperatively. Postoperatively, at the end of 90 days, the ulcers of three patients got completely healed and the ulcer of one patient got partially healed.
There is a significant difference in the hospital stay between the open surgery and laser surgery groups. Laser surgery is associated with a shorter duration of hospital stay. The average duration of hospital stay in the laser surgery group was 2.02 days and that in the open surgery was 4.17 days. Van den Bos et al. establish that EVLA can be done as a safe outpatient procedure.[15]
Ecchymotic patches, transient numbness and wound infection were the major complications encountered. While ecchymotic patches and transient numbness/paraesthesia were observed in both groups with no statistically significant differences, wound infection was encountered only in the open surgery (saphenofemoral ligation and stripping) group. Both groups were given prophylactic antibiotics. The wound infection rate was statistically significant and was present in 13 persons out of 53 persons in the open surgery group. In the vast majority of cases, it was a milder superficial surgical site infection (SSI). Only one person required additional treatment in the form of a change in the antibiotic. The EVLT group does not report even a single case of SSI. Corder et al. report an overall wound infection rate of 13.7% observed following high saphenous ligation.[16]
The improvement in the quality of life was measured using EQ VAS and EQ 5D questionnaire. EQ VAS was used to measure the quality of life preoperatively and POD 90. There was a significant difference in the pre-operative and post-operative quality of life in the EVLA group and saphenofemoral ligation and stripping group. Further, it can also be assumed that EVLA is at least as good as saphenofemoral ligation and stripping, in improving the overall quality of life of varicose vein patients at the end of POD 90.
EQ 5D score was used to measure the quality of life of both groups preoperatively and postoperatively on POD 7 and 90 days. The EQ 5D questionnaire encompasses 5D for the assessment of one's quality of life and includes mobility, self-care, usual activities, pain and anxiety. In my study, the quality of life of EVLA group showed a significant difference from that of the saphenofemoral ligation and stripping group on POD 7. Statistical analysis of EQ 5D scores of POD 90 shows no statistically significant difference between the EVLA group and the open surgery group.
Rass et al. conducted a randomised clinical trials comparing EVLA and high ligation and stripping of the GSV. They measured the disease-specific quality of life by the chronic venous insufficiency questionnaire-2. They have drawn similar conclusions that both procedures improve the quality of life of the patient.[17]
| Conclusion | | |
Patients treated by EVLA enjoyed a better quality of life from the early post-operative periods itself and were able to return to their normal activities much earlier than the saphenofemoral ligation and stripping group. Significant reduction in the post-operative pain, the absence of wound infection and a significant reduction in the clinical severity scores are the other factors that have promoted enhanced recovery and early return to normal life. EVLA is a safer and effective means for treating varicose veins. Based on the study we recommend that EVLA should be used as the treatment method of choice for complicated and uncomplicated cases of varicose vein disease. In addition, it provides cosmetically superior results, EVLA offers faster improvement in the quality of life of patients. Minimally invasive and highly effective techniques like EVLA should be made available to the common people at a cheaper rate.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Van den Bos RR, Kockaert MA, Neumann HA, Nijsten T. Technical review of endovenous laser therapy for varicose veins. European J Vas Endovas Surg 2008;35:88-95.  |
| 2. | Joseph N, Abhisha B, Faizan Thouseef M, Devi MU, Abna A, Juneja I. A multicenter review of epidemiology and management of varicose veins for national guidance. Ann Med Surg (Lond) 2016;8:21-7. |
| 3. | Subramonia S, Lees TA. The treatment of varicose veins. Ann R Coll Surg Engl 2007;89:96-100. |
| 4. | Kompally GR, Bharadwaj RN, Singh G. Varicose veins: Clinical presentation and surgical management. Indian J Surg 2009;71:117-20. |
| 5. | Boersma D, Kornmann VN, van Eekeren RR, Tromp E, Ünlü Ç, Reijnen MM, et al. Treatment modalities for small saphenous vein insufficiency: Systematic review and meta-analysis. J Endovasc Ther 2016;23:199-211. |
| 6. | Michaels JA, Brazier JE, Campbell WB, MacIntyre JB, Palfreyman SJ, Ratcliffe J. Randomized clinical trial comparing surgery with conservative treatment for uncomplicated varicose veins. Br J Surg 2006;93:175-81. |
| 7. | Rathod J, Taori K, Joshi M, Mundhada R, Rewatkar A, Dhomane S, et al. Outcomes using a 1470-nm laser for symptomatic varicose veins. J Vasc Interv Radiol 2010;21:1835-40. |
| 8. | Christenson JT, Gueddi S, Gemayel G, Bounameaux H. Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up. J Vasc Surg 2010;52:1234-41. |
| 9. | |
| 10. | |
| 11. | Chang SL, Huang YL, Lee MC, Hu S, Hsiao YC, Chang SW, et al. Association of varicose veins with incident venous thromboembolism and peripheral artery disease. JAMA 2018;319:807-17. |
| 12. | Bass A. The effect of standing in the workplace and the development of chronic venous insufficiency. Harefuah 2007;146:675-6, 734-5. |
| 13. | |
| 14. | |
| 15. | Van den Bos RR, Kockaert MA, Neumann HA, Nijsten T. Technical review of endovenous laser therapy for varicose veins. European J Vas Endovas Surg 2008;35:88-95. |
| 16. | Corder AP , Schache DJ, Farquharson SM, Tristram S. Wound infection following high saphenous ligation. A trial comparing two skin closure techniques: subcuticular polyglycolic acid and interrupted monofilament nylon mattress sutures. J R Coll Surg Edinb 1991;36:100-2. Available from: https://pubmed.ncbi.nlm.nih.gov/1646881/. [Last accessed on 2021 Sep 20]. |
| 17. | Rass K, Frings N, Glowacki P, Hamsch C, Gräber S, Vogt T, et al. Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: Two-year results of a randomized clinical trial (RELACS study). Arch Dermatol 2012;148:49-58. |
[Table 1], [Table 2], [Table 3]
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