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 12 sources, which was discussed by the committee. The evidence included 3 comparative studies, 4 case series (one of which was reported in 2 separate phases), data provided by the ERUS RAKT registry, and safety data from 3 conference abstracts. These are presented in table 2 of the interventional procedures overview. Other relevant literature is in appendix A of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: patient survival, graft survival and renal function.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: blood loss, warm ischaemia time, conversion to open surgery, arterial thrombosis, loss of renal function, infection and graft rejection.
3.4 Patient commentary was sought but none was received.
3.5 Most of the evidence was from studies in patients with obesity for whom conventional transplant surgery was not suitable, and this supported recommendation 1.1.
3.6 Most of the evidence came from studies in which kidneys were retrieved from living donors.
3.7 The committee was advised that the placement of the transplant kidney within the peritoneum may increase risk of torsion of the kidney and make biopsy difficult. However, a technique to fix the kidney in an extra-peritoneal pouch has been developed, aiming to prevent vascular torsion and allowing biopsy.
3.8 The committee was told that there is a substantial learning curve for surgeons wishing to do this procedure.