Does subfascial endoscopic perforator surgery (leg-vein surgery) help heal venous leg ulcers?

What is the aim of this review?

Subfascial endoscopic perforator surgery (SEPS) involves cutting and closing off damaged perforator veins (blood vessels that link superficial and deep veins) in the leg. The aim of this review was to find out whether SEPS can help heal venous leg ulcers (slow-healing skin wounds caused by poor blood flow through leg veins). We collected and analysed all relevant randomised controlled trials (a type of study in which participants are assigned to one of two or more treatment groups using a random method, which provides the most reliable evidence) to answer this question and identified four studies for inclusion.

Key messages

It is uncertain whether SEPS is beneficial or safe as a treatment for venous leg ulcers, as the certainty of the evidence collected is low or very low, and the included studies involved small numbers of participants.

What was studied in the review?

Venous leg ulcers are a common and costly health problem. These chronic wounds often take months to heal and have a high chance of recurrence after healing. Venous leg ulcers can be caused by veins that do not work properly, which results in blood flowing in the wrong direction between the superficial and deep veins in the leg. Blood that does not flow correctly causes increased pressure and inflammation, leading to skin breakdown and ulceration in the lower leg. Subfascial endoscopic perforator surgery can prevent blood from flowing in the wrong direction by cutting and tying veins that link the superficial and deep veins. It is unclear if SEPS is more effective than other treatment options such as compression bandages or stockings, which are the standard treatment for venous leg ulcers. We therefore investigated if this surgical technique can help venous leg ulcers heal more quickly. We also considered whether the surgery had any side effects, and if it impacted study participants' quality of life, experience of pain, or time spent in hospital and nursing care.

What are the main results of the review?

We included four studies in the review which dated from 1997 to 2011 and compared SEPS with other treatments for venous leg ulcers. The studies involved a total of 322 participants, ranging in age from 30 to 82 years, with an equal number of males and females.

Two studies compared SEPS and compression stockings with compression alone; one study compared SEPS against the Linton surgical procedure (a type of open surgery on leg veins); and one study compared SEPS in addition to saphenous vein surgery (surgery on the largest superficial vein in the leg) versus saphenous vein surgery alone.

We concluded that the evidence is insufficient to determine if SEPS results in better, worse, or the same outcomes as compression treatment in terms of ulcer healing. There may be a benefit of SEPS in terms of proportion of ulcers healed at 24 months, however evidence for this is of low certainty. It is also unclear due to the very low certainty of the evidence if SEPS as an addition to saphenous surgery, or as compared to the Linton approach, makes any difference in venous leg ulcer healing. No studies reported on quality of life, serious side effects or home nursing care requirements for study participants.

All four studies were small in size, with the largest including 200 participants, and the other three studies reporting on 75 participants or fewer. This factor, along with poor study design methods, means that the evidence about the role of SEPS in treating venous leg ulcers is of low or very low certainty. It therefore remains unclear whether SEPS is beneficial or safe in venous leg ulcer treatment, and further high-quality studies with larger sample sizes are likely to change the conclusions of this review.

How up-to-date is this review?

We searched for all studies published up to March 2018.

Authors' conclusions: 

The role of SEPS for the treatment of venous leg ulcers remains uncertain. Only low or very low-certainty evidence was available for inclusion. Due to small sample sizes and risk of bias in the included studies, we were unable to determine the potential benefits and harms of SEPS for this purpose. Only four studies met our inclusion criteria, three were very small, and one was poorly reported. Further high-quality studies addressing the use of SEPS in venous leg ulcer management are likely to change the conclusions of this review.

Read the full abstract...
Background: 

Venous leg ulcers are complex, costly, and their prevalence is expected to increase as populations age. Venous congestion is a possible cause of venous leg ulcers, which subfascial endoscopic perforator surgery (SEPS) attempts to address by removing the connection between deep and superficial veins (perforator veins). The effectiveness of SEPS in the treatment of venous leg ulcers, however, is unclear.

Objectives: 

To assess the benefits and harms of subfascial endoscopic perforator surgery (SEPS) for the treatment of venous leg ulcers.

Search strategy: 

In March 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

Selection criteria: 

We included randomised controlled trials (RCTs) of interventions that examined the use of SEPS independently or in combination with another intervention for the treatment of venous leg ulcers.

Data collection and analysis: 

Two review authors independently selected studies for inclusion, extracted data, assessed risk of bias, and assessed the certainty of evidence using the GRADE approach.

Main results: 

We included four RCTs with a total of 322 participants. There were three different comparators: SEPS plus compression therapy versus compression therapy (two trials); SEPS versus the Linton procedure (a type of open surgery) (one trial); and SEPS plus saphenous surgery versus saphenous surgery (one trial). The age range of participants was 30 to 82, with an equal spread of male and female participants. All trials were conducted in hospital settings with varying durations of follow-up, from 18 months to 6 years. One trial included participants who had both healed and active ulcers, with the rest including only participants with active ulcers.

There was the potential for reporting bias in all trials and performance bias and detection bias in three trials. Participants in the fourth trial received one of two surgical procedures, and this study was at low risk of performance bias and detection bias.

SEPS + compression therapy versus compression therapy (2 studies; 208 participants)

There may be an increase in the proportion of healed ulcers at 24 months in people treated with SEPS and compression therapy compared with compression therapy alone (risk ratio (RR) 1.17, 95% confidence interval (CI) 1.03 to 1.33; 1 study; 196 participants); low-certainty evidence (downgraded twice, once for risk of bias and once for imprecision).

It is uncertain whether SEPS reduces the risk of ulcer recurrence at 24 months (RR 0.85, 95% CI 0.26 to 2.76; 2 studies; 208 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).

The included trials did not measure or report the following outcomes; time to complete healing, health-related quality of life (HRQOL), adverse events, pain, duration of hospitalisation, and district nursing care requirements.

SEPS versus Linton approach (1 study; 39 participants)

It is uncertain whether there is a difference in ulcer healing at 24 months between participants treated with SEPS and those treated with the Linton procedure (RR 0.95, 95% CI 0.83 to 1.09; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).

It is also uncertain whether there is a difference in risk of recurrence at 60 months: (RR 0.47, 95% CI 0.10 to 2.30; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).

The Linton procedure is possibly associated with more adverse events than SEPS (RR 0.04, 95% CI 0.00 to 0.60; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).

The outcomes time to complete healing, HRQOL, pain, duration of hospitalisation and district nursing care requirements were either not measured, reported or data were not available for analysis.

SEPS + saphenous surgery versus saphenous surgery (1 study; 75 participants)

It is uncertain whether there is a difference in ulcer healing at 12 months between participants treated with SEPS and saphenous surgery versus those treated with saphenous surgery alone (RR 0.96, 95% CI 0.64 to 1.43; 1 study; 22 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).

It is also uncertain whether there is a difference in the risk of recurrence at 12 months: (RR 1.03, 95% CI 0.15 to 6.91; 1 study; 75 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).

Finally, we are uncertain whether there is an increase in adverse events in the SEPS group (RR 2.05, 95% CI 0.86 to 4.90; 1 study; 75 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).

The outcomes time to complete healing, HRQOL, serious adverse events, pain, duration of hospitalisation, and district nursing care requirements were either not measured, reported or data were not available for analysis.

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