3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 8 sources, which was discussed by the committee. The evidence included 2 systematic reviews, 1 non-randomised comparative study, 3 case series and 2 case reports, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: pain reduction, improvement in Oswestry Disability Index scores, and quality of life.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: bowel perforation, damage to adjacent structures, revision surgery, bleeding, and infection.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that there was a risk of bowel perforation because of this procedure and that in patients who had this complication, many needed a colostomy.
3.6 The committee was told that most patients having the procedure also have posterior fusion surgery at the same time.
3.7 The committee was told that the technique has evolved over time and much of the evidence reviewed by the committee was from an older version of the device.