Economic evaluation of the treatment of grade II haemorrhoids: a comparison of stapled haemorrhoidopexy and rubber band ligation.

OBJECTIVES Haemorrhoidal disease is a common condition causing considerable distress to individuals and significant cost to healthcare services. This paper explored the cost-effectiveness of stapled haemorrhoidopexy (SH) compared with the non-surgical intervention, rubber band ligation (RBL), for grade II symptomatic circumferential haemorrhoids. METHOD An economic evaluation alongside a randomized controlled trial conducted between October 2002 and February 2005. Adults were recruited and randomized to either SH or RBL. The same surgeon performed all procedures and investigators were blinded until analyses were completed. Primary outcomes measured at 52 weeks were cumulative costs to the NHS, clinical diagnosis of recurrence and quality adjusted life years (QALYs). RESULTS Sixty symptomatic men and women with confirmed clinical diagnosis of grade II symptomatic haemorrhoids were randomized. Loss to follow-up was up to 10% at 52 weeks. The mean cost for SH was greater than RBL (mean difference: 1483 pounds, 95% CI: 1339-1676); disease recurrence was lower (OR = 0.18, 95% CI: 0.03-0.86); and there was no evidence of a statistically significant difference in QALYs (-0.014, 95% CI: -0.076 to 0.051). SH was associated with a modest incremental cost per recurrence avoided at 12 months follow-up (4945 pounds). Based on current data, it was considered highly unlikely to be cost-effective in terms of incremental cost per QALY. CONCLUSIONS There is insufficient evidence about the cost-effectiveness of SH for grade II haemorrhoids to recommend its routine use in place of RBL. Further information is needed from larger trials with a longer-term follow-up to inform subsequent economic evaluation.