General considerations

We hypothesised that RBLs is non-inferior to a haemorrhoidectomy for the outcome QOL. The economic evaluation of RBLs against haemorrhoidectomy will be performed as a cost–utility analysis (CUA) from a societal perspective with the cost per QALY as the main outcome measurement. The CUA can be used for policy making and composition of a guideline. We will base the CUA on a time horizon of 24 months, because we expect that differences in health outcomes and costs will be presented in the first 24 months. No discounting of effects and costs will be done. Furthermore, a CUA with a lifelong time horizon will be made using extrapolation and model based techniques. To account for uncertainties, a probabilistic sensitivity analysis will be performed.

Incremental cost-effectiveness ratios will be calculated as the difference in costs per QALY sampling variability in the 24 months time horizon. CUA will be accounted for by bias-corrected and accelerated non-parametric bootstrapping. Results will be reported along with their 95% CIs and displayed graphically with cost-effectiveness planes and with cost-effectiveness acceptability curves. One-way and multiway sensitivity analyses will be done for the unit costs of healthcare.