Subfascial endoscopic perforator surgery (SEPS) for treating venous leg ulcers.

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 METHODS 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 We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of included studies as well as reviews, meta-analyses and health technology reports to identify additional studies.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. 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.