Abstract
Objective
The first two authors contributed equally to this work.
Methods
Female patients undergoing vein surgery were randomized for a compression therapy with low (18–21 mmHg, group A) or moderate (23–32 mmHg, group B) pressure MCSs. Follow-up was done by a phlebological experienced, blinded physician (pressure control, clinical aspect, duplex scan, and questionnaire) one and six weeks after surgery.
Results
Totally, 88 patients (41 in group A and 47 in group B) were analyzed. One week after surgery, patients of group B had significantly lower edema scores than patients of group A either in the clinical assessment (0.7 vs. 0.3; p = 0.016) or in the B-mode scan (0.9 vs. 0.4; p = 0.013). Significant less patients of group B had a feeling of “tightness” (p = 0.01) and significant more a reduction of discomfort (p = 0.01) after week 1 but with no significance in week 6. There was no significant difference according to other clinical and ultrasound findings such as hematoma, infection, hyperpigmentation, cording, or thrombosis after one or six weeks. In week 1 and week 6, more patients suffered from pain in group A (week 1 p = 0.24, week 6 p = 0.063). Application of the MCSs was easier in group A in week 1 but similar in groups A and B in week 6. Muscle vein thrombosis occurred in one patient of group A.
Conclusion
Compression stockings with a pressure of 23–32 mmHg facilitate a faster resolution of clinical and ultrasound verified edema and the subjective feelings of pain, tightness, and discomfort of the leg in the early period after surgery but have no difference in the longer post-surgical period compared to stockings with a pressure of 18–21 mmHg.
Introduction
Varicose veins (C2) and more severe stages of chronic venous insufficiency (CVI) (C3–C6) are very common diseases in western industrial nations and are therefore expensive diseases in the socioeconomic system of western industrial nations.1,2 In Germany, in 2006, vein surgery was one of the most frequent surgical treatments. 3 Although, alternative treatments such as endoluminal radiowave, laser, or foam sclerotherapy have been invented and evaluated during the past decades, there are still indications for venous surgery.
In several studies, compression therapy could be evaluated as an efficient and safe therapy in the treatment of chronic venous insufficiency of different stages.4,5 It is also unquestionably a corner stone in the post-surgical treatment. But there is still no evidence for the optimal dose and duration of the treatment after venous surgery. 5
There is evidence that patients with varicose veins and more severe chronic venous insufficiency tend to wear compression stockings with lower compression for comfort reasons and for an easier application of the treatment.6–9 Furthermore, the effect of compression stockings with a pressure of 40 mmHg and 15 mmHg seems to be comparable in the conservative treatment. 10 However, most patients in Germany get a compression stocking with a moderate pressure of 23–32 mmHg after venous surgery.
Therefore, the aim of this study was to evaluate the efficacy, safety, and comfort of round knitted compression stockings with low (18–21 mmHg) and moderate (23–32 mmHg) compression for six weeks after vein surgery to at least one leg.
Methods
Patients and procedures
Design
Inclusion and exclusion criteria of the study.
Surgery procedures
Admitted surgery procedures were flush-ligation and stripping of the great or small saphenous vein, phlebectomy of tributaries, ligation of perforating veins, phlebectomy of recurrent veins, and re-surgery of the saphenofemoral or saphenopopliteal junction. There was no surgery to the great and small saphenous vein of one leg in any of the patients. The surgery procedures were done by a team of experienced vein surgeons.
Compression stockings
According to the compression therapy, patients were randomized consecutively into group A (18–21 mmHg) or B (23–32 mmHg). All patients got the same type of thigh-high (AG), round knitted compression stocking (Mediven elegance) with different ankle pressure (low vs. moderate). The compression stocking was adjusted by an experienced associate of a medical supply store who regularly adjusts and sells compression stockings.
When allocating the compression stockings to the patients, the fitting of the stockings was controlled and pressure at the lower leg of the patient, sitting and standing, was measured by a sub-bandage pressure monitor with a small probe (KIKUHIME, TTMediTrade®, Denmark). Patients were advised to wear their compression stockings throughout the whole day, for at least 8 h/day, to pull them on in the morning after getting up and to take them off before going to bed. In the case of any misfitting, they should document this in the questionnaires and address this to the cooperating medically supply store. Initially, all patients got the same rubber gloves as a device for facilitating easier application of the stockings.
Follow-up
Finally, follow-up visits for the study were done one week and six weeks after surgery with:
A questionnaire, answered by the patient with multiple choice, free answers and a final whole assessment of the stocking graded from 1 (very good) to 6 (unsatisfactory). Patients voted by themselves. They compared impressions with/without stockings (e.g., reduction of discomfort) after one and six weeks after surgery. Furthermore, they evaluated the handling, pulling, and wearing of the stockings. Clinical evaluation of the leg with semi-quantitative scales for the severity of hematoma, cording, edema, and infection (0 = none, 1 = low, 2 = medium, and 3 = strong) in the region of surgery. B-mode imaging of the leg with semi-quantitative scales for the severity of hematoma and edema (0 = none, 1 = low, 2 = medium, and 3 = strong) (Sonoline G60S, Acuson X300, and Acuson Antares; all products: Siemens, Germany) in the region of surgery. Duplex scan of the leg veins to verify or exclude thrombophlebitis or deep vein thrombosis (Sonoline G60S, Acuson X300, and Acuson Antares; all products: Siemens, Germany).
In the post-surgical follow-up visits, the physician was blinded according to the type of compression stocking. The clinical examination of the leg and the duplex scan was done according to a standardized protocol one week and six weeks after surgery.
The ultrasound B-mode was used to obtain further information on fluid layers in the subcutaneous tissue and to see the length and extent of subcutaneous hematoma.
Ethics
The terms of the protocol comply with the declaration of Helsinki. The protocol was voted by the ethics committee of the Ruhr-University Bochum (No. 3514-09MPG).
Statistics
The data were analyzed using SPSS Statistics 19, first descriptively, and then with the use of a t-test for independent samples. Categorized variables were analyzed by using a chi-square test. A value of p < 0.05 was regarded as significant.
Results
Patients
The inclusion period was between February 2010 and February 2011. During this period, about 1000 venous surgery procedures were carried out in our center. Just about 10% of the patients fulfilled the inclusion criteria (Table 1) and were willing to take part in the study with controls after one and six weeks.
Reasons for patients missing during the study period.
Basic data of the patients analyzed.
GSV: great saphenous vein; SSV: small saphenous vein. In none of the patients, there was a stripping of the GSV and the SSV on the same leg.
Pressure at the lower leg
The pressure of the new stockings at the B-Mark (ankle region) was higher than that supposed in group A (22.55 ± 3.64 mmHg, German class 1 = 18–21 mmHg) and that in group B (29.48 ± 3.75 mmHg, German class 2 = 23–32 mmHg). The pressure at B and B1 had just a slight difference. Within the lower leg, we recorded a constant decrease of pressure from the B-Mark up to the knee (Figure 1).
Average pressure of the compression stockings at the lower leg (B-Mark, +7, +14, +21, +28 cm) in the sitting patient in mmHg in group A and group B.
Clinical and ultrasound findings after one and six weeks
After one week, both in the clinical (Table 4) and in the sonographic findings (Table 5), there was a significant reduction of edema in group B compared to group A (Figure 2). On the clinical scale from 0 to 3, an average of 0.298 ± 0.657 in group B versus 0.707 ± 0.901 in group A was seen (p = 0.016). The result was also significant regarding the ultrasound analysis data (p = 0.013).
One week after surgery, patients of group B had significantly lower edema scores than patients of group A either in the clinical assessment (0.7 vs. 0.3; p = 0.016) or in the B-mode scan (0.9 vs. 0.4; p = 0.013). Clinical findings of both groups – groups A (low compression) and B (moderate compression) after one and six weeks voted with semi-quantitative scales for the severity of hematoma, cording, edema and infection (0 = none, 1 = low, 2 = medium, 3 = strong) in the region of surgery. There was significantly less edema in group B after one week but no significant differences in week 6. Ultrasound findings of both groups – groups A (low compression) and B (moderate compression) voted with semi-quantitative scales for the severity of hematoma and edema (0 = none, 1 = low, 2 = medium, 3 = strong) in the region of surgery. Edema was significantly less frequent after week 1 in group B but there were no significant differences in week 6.
One week after surgery, 70.2% of group B but only 46.3% of group A had no clinical signs of edema (p = 0.02). Furthermore, the apparent edema was less in group B compared to group A.
Thromboembolic side effects
In group A, there was one patient with a deep venous thrombosis of a muscle vein after flush ligation and saphenectomy of the small saphenous vein of the right leg. In the medical history, this patient had already had thrombophlebitis of a tributary.
Pain and discomfort in week 1 and 6 from the patients’ view
Post-surgical side effects of both groups from the patients’ view in the two groups A (low compression) and B (moderate compression).
Patients voted with “yes” or “no.”
It was remarkable that both in week 1 (46.3% vs. 34.0%; p = 0.24) and in week 6 (19.5% vs. 6.4%; p = 0.063), more patients of group A suffered from pain than in group B.
One week after surgery, 14.6% of group A but 38.3% of group B reported a reduction of discomfort in the leg (p = 0.013). After six weeks, the difference was not significant anymore (p = 0.419), by tendency there was still a slight advantage in group B (42.6% vs. 34.1%).
Simultaneously, 12.2% of group A but 0% in group B reported a “tightness” in the leg one week after surgery (p = 0.014). After six weeks, the difference was not significant anymore.
After six weeks, 90% of group A but only 77.8% of group B recorded that they were “satisfied” with their kind of compression treatment (p = 0.285). 11.1% of group B and 5% of group A were not willing to continue the compression treatment after the six weeks.
The main adversities under the compression stockings in both groups were dryness of the skin (47% after one week and 60% after six weeks), desquamation (20% and 22%, respectively), and itching (20% and 20%, respectively). There were no significant differences between the two groups.
Compliance after six weeks
Eighty-four patients (95.5%) wore the compression stockings during the day and 4 (4.6%) even during night and day. There was no significant difference between the two groups according to the wearing time per day (p = 0.376). Most patients wore the stockings between 12 and 18 hours a day (n = 53, 60.2%; Figure 3). There was a slight tendency in group A for a longer wearing time during the day but no significant difference (p = 0.428).
Compliance after six weeks in both groups. There was a slight tendency for a longer wearing time per day in group A (low compression).
The comfort of wearing compression stockings was recorded as “good” after one and six weeks in both groups (Figure 4). Most patients regarded the medical compression stocking (MCS) as comfortable or functional. Some patients gave multiple answers.
Answers to the question “How do you regard the wearing of compression stockings?” There were slight but not significant differences between the groups (p = 0.501). MCS: medical compression stocking.
Application of the stockings
Patients recorded the comfort of application on a 10-point scale, i.e., from 1 (easy) to 10 (not able to cope). During the first post-surgical week, application of the low compression stockings (group A) was reported to be significantly easier than of the moderate (group B) compression stockings (3.6 vs. 4.9; p = 0.010). Surprisingly, after six weeks, the patients of group B showed a slight tendency to easier application of their compression stockings (3.3 vs. 2.8; p = 0.240).
After six weeks, most of the patients were able to apply their stockings without any help (58.8%) or by using rubber gloves (42.1%). There was no significant difference between the two groups.
No difference in global voting after one and six weeks
Finally, patients recorded for their compression treatment by using a six-step scale (1 = very good, 2 = good, 3 = satisfying, 4 = fair, 5 = bad, and 6 = fail). After one (p = 0.78) and six weeks (p = 0.80), there were no significant differences between the two groups.
Discussion
Compression treatment has been a main corner stone following venous surgery for years. It could be shown that it is protective against hematoma, thrombophlebitis, and edema and reduces pain after surgery.4,11–13 However, the optimal dose and duration of compression treatment after surgery are still unclear. This pilot study compared the efficacy and safety of round knitted compression stockings with low and moderate pressure for six weeks after venous surgery.
For better reliability of the results, we only included female patients who were able to be fitted with the study stocking (Mediven elegance AG class I or II). Patients who would need a higher degree of stiffness or a different kind of compression device (e.g., compression tights or knee-high compression stockings) were excluded from the study. Thus, we worked with a homogenous collective without significant differences in basic data.
The results of the study show that there is an argument for compression treatment with higher pressure especially in the initial period after surgery. In the clinical assessment, a significant reduction of edema could be seen clinically (p = 0.016) and by ultrasound (p = 0.013) in group B. The stocking with the higher pressure reduced the post-surgical edema. After one week, in group A 46.3% were free of edema in contrast to 70.2% of group B. In a study on CVI patients with corona phlebectatica (former Widmer I), edema, and skin complications (former Widmer 2) of CVI, similar results could be seen. The most effective reduction in the volume of the lower limb was possible with compression stockings of class II (23–32 mmHg) compared to class I (18–21 mmHg) or a support stocking. 9 Another study proposed higher compression (50–60 mmHg) in the initial period in patients with venous leg ulcers in order to reduce the leg edema. In the follow-up, pressure can be reduced to 30–40 mmHg. Thus, even in ulcer patients, an initially higher pressure seems to be more effective in reducing leg edema. 14 A further strong increase of pressure does not seem to be effective. There was a recent study of 30 patients treated with different kinds of compression for chronic leg edema caused by venous stasis. Finally, compression stockings exerting a pressure around 30 mmHg are nearly as effective as high-pressure bandages with an initial pressure over 60 mmHg in reducing chronic leg edema. 15
The complaints of the patients after venous surgery could be reduced under compression treatment in all patients in the current study. Comparing both groups after one and six weeks, more patients with low compression had pain (46.3% vs. 34% after one week and 19.5% vs. 6.4% after six weeks). As pain is known to have a negative impact on the quality of life, this result is important. Up to now, there were no data regarding edema and pain in the post-surgical period. We only know from the Bonn Vein Study that compression treatment is effective in reducing CVI-induced pain in about 60%. 1 These positive effects are also confirmed by the studies investigating compression stockings and bandages in venous leg ulcers. 16 However, there is a difference between the need to control venous hypertension for ulcer healing and post-surgical edema following vein ablation. In another study comparing compression with 40 mmHg and 15 mmHg after venous surgery, by tendency the higher pressure was inferior to the lower pressure as more patients with higher compression complained about discomfort (35.3% vs. 29.2%). 17 In the clinical assessment of thrombophlebitis, there was no difference between both groups (9.8% vs. 10.4%). 17 In this study, patients have more reduction in pain, tightness, and edema by wearing the moderate compression (23–32 mmHg). The rate of thromboembolic events was also very low in both groups. In the controls after one and six weeks after surgery, we just had one case of muscle vein thrombosis in group A in a patient with a former thrombophlebitis. With regard to clinical parameters and personal comfort, the “ideal” compression for the post-surgical period seems to be moderate compression stockings.
The compliance in this study was quite good in both groups. From other studies, it is known that compliance with compression is often bad.18,19 But it is hard to discuss what optimal compliance means – e.g., wearing compression every day, for a special number of hours every day, for special risk situations. It is reasonable that compliance is better in situations with short-term necessity for compression treatment rather than for a life-long necessity for compression treatment. 20 In this study, patients know that they have to wear the compression treatment for a defined period of time for the prophylaxis of thrombosis.
After venous surgery, compression stockings seem to be more comfortable than compression bandages. 13 Often, compliance is influenced by side effects of the treatment. From other studies, it is known that too high or too low pressure, dryness and redness of the skin, as well as itching are main complaints.20–22 In the current group, the main adverse events with the compression stockings were also dryness of the skin, desquamation, and itching in both groups without significant differences.
Surprisingly, application of the compression stockings was similar in both groups after six weeks. While in the first week more patients of group B complained of difficulties with the application of the stocking, after six weeks by tendency these patients even had a slight advantage compared to group A. Perhaps this fact can be explained by the training effect. From week 1 to 6, patients learned better handling of their compression treatment by pulling the stockings on and off every day. All patients had rubber gloves as an aid, only a few needed more technical support. From other studies, we know that the stocking with the lower compression is normally voted to be easier to put on.6–9
According to the data of this study and the data of literature, a moderate (23–32 mmHg) or even strong compression (>33 mmHg) during the first period would be helpful to reduce initial edema, swelling, and pain. It has to be determined whether a strong compression in the initial period after surgery, e.g., for just one to two weeks, is as effective as a compression treatment for six weeks.
Furthermore, it has to be discussed whether lower pressure and higher stiffness would be an alternative to reach the same results. Also, it has been shown that low compression with high stiffness (inelastic bandages, 20 mmHg) can reach a significant increase of the venous ejection fraction (+61.5%, p < 0.01). 15 Perhaps compression with such parameters is easier to handle but has the same clinical effect. These aspects could be the topic of further studies.
Limitations
Unfortunately, 18.5% of the patients initially included were lost in follow-up as they were not willing or able to attend the visits after one or six weeks. Just one patient was excluded from the study for medical reasons. It can be assumed that the patients that did not come back for the planned post-surgical visits did not see a medical need for this. Perhaps they had less pain or fewer problems with their legs than those who came back for the follow-up visits.
Furthermore, it is hard to separate those patients who are satisfied with their compression treatment from those who are satisfied with their surgery as a whole. The questionnaires strictly focused on the compression therapy. Additionally, we always remind the patients to give their assessment for the stockings instead of the surgical treatment. But finally, we could not completely exclude this influence.
As this study was a pilot study on compression after venous surgery experience according objective parameters were missing. On the basis of the now known data, it would be helpful for further studies to calculate the sample size before the study, to deal with more objective parameters (e.g., measurement of the subcutaneous tissue) instead of semi-quantitative evaluations suggested by the physicians.
Conclusion
In conclusion, we see an advantage for a moderate compression (23–32 mmHg) in the initial period after surgery. Particularly, edema and tightness can be reduced more effectively in the first week. The adverse effects such as dryness of the skin, desquamation, and itching provoked by the stocking after six weeks were independent of the compression pressure. Therefore, it has to be determined whether short strong compression treatment after the surgical intervention is sufficient. Further studies are necessary to evaluate different periods of compression therapy after surgery.
Footnotes
Acknowledgements
We thank the very kind staff of the cooperating seller of medical compression stockings – especially Mrs Cornelia Leiendecker.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Conflict of interest statement
The authors have no conflicts of interest to declare.
