Outcomes of electrically stimulated gracilis neosphincter surgery.

OBJECTIVES To examine patient quality of life (QoL) and long-term costs of electrically stimulated gracilis neosphincter surgery (ESGNS). DESIGN Independently conducted prospective case-comparison study of patients at the Royal London Hospital (RLH), plus a cross-sectional study of outcomes of ESGNS performed at three other UK centres. PARTICIPANTS Cases were patients who underwent ESGNS at the participating hospitals during a 5-year period from 1977. Comparisons were made with two groups of people with similar bowel disorders who did not undergo ESGNS. INTERVENTION ESGNS is a procedure designed to improve bowel function for people living with severe faecal incontinence or stomas. It involves transposition of the gracilis muscle to form a neo-anal sphincter. The transposed muscle is electrically stimulated via an electronic pulse generator implanted beneath the skin of the abdomen. MAIN OUTCOME MEASURES Clinical success and symptomatic outcomes of surgery. Generic, domain and condition specific measures of QoL. Comparative costs to the NHS of ESGNS and conventional alternatives. RESULTS At 3 years after surgery approximately three-quarters of patients still had functioning neosphincters. At this stage, bowel-related QoL and continence improved by more than 20% for nearly two-thirds of RLH patients. However, ongoing bowel evacuation difficulties occurred in half of those with good continence outcomes. QoL improvements were maintained in the smaller group of RLH patients who had reached 4 and 5 years of follow-up, although at this stage the proportion with failed neosphincters had increased. The RLH findings were supported by those from the three other UK centres. No significant changes in QoL were observed in the comparison groups during the follow-up period. The mean cost of patient care at RLH, was 23,253 pounds. In the other three centres, the estimated mean cost of the intervention per patient was 11,731 pounds, reflecting fewer planned operations and repeat admissions. Costs of patient care for those with stomas who did not undergo ESGNS were estimated at 2125 pounds per patient-year and for those who remained with severe faecal incontinence, 442 pounds per patient-year. For patients with prior faecal incontinence, a decision to refer to ESGNS resulted in a cost-effectiveness ratio, estimated over 25 years of follow-up, of between 30,000 pounds and 40,000 pounds per quality-adjusted life-year (QALY) gained, depending on centre. The choice of stoma for these patients resulted in a slightly higher cost than ESGNS. For those with prior stoma, referral to ESGNS resulted in a cost-effectiveness ratio of between 5000 pounds and 15,000 pounds per QALY gained, depending on the centre. Cost-effectiveness ratios of around 30,000 pounds per QALY gained are generally regarded to be reasonably attractive in the UK NHS context. CONCLUSIONS Although ESGNS is a major procedure associated with a high rate of long-term failure and bowel evacuation difficulty, it could be considered as an option at the extreme end of the treatment spectrum for refractory faecal incontinence. A strategy to refer patients for ESGNS would be regarded as cost-effective for patients already with stoma, whilst on the margin of cost-effectiveness for patients initially being managed conservatively.