Cost-effectiveness of three routes of hysterectomy: a multi-centre randomized controlled trial

Abstract

BACKGROUND: Hysterectomy is the commonest major gynaecological surgical procedure. The aim of this study was to evaluate the cost-effectiveness of non-descent vaginal hysterectomy (NDVH) and total laparoscopic hysterectomy (TLH) compared to total abdominal hysterectomy (TAH). METHODS: A randomized controlled trial was conducted at the gynaecology unit, District General Hospital, Mannar and professorial gynaecology unit, North Colombo Teaching Hospital, Ragama. Study population (n=49 per arm) were women needing hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus  14 weeks, previous pelvic surgery, those requiring incontinence/pelvic floor surgery, comorbidities which preclude laparoscopic surgery and women who were illiterate. Primary outcome was the time to recover following hysterectomy which was considered as the earliest time to resume activities done prior to surgery. A Kaplan-Meier survival analysis was done with pairwise comparison through log-rank test for the primary outcome. A micro-costing approach calculated utilization of hospital resources from the time of presentation up to six months after surgery. Incremental costeffectiveness ratios (ICER) were obtained by calculating the incremental costs divided by the incremental effects (time to recover) for the intervention groups (NDVH and TLH) over the standard care (TAH) group. RESULTS: The overall combined results from both centres did not show a significant difference in time to recover (median, 95% confidence interval) between TLH [30 days (29.0-31.0)], NDVH [32 days, (28.3-35.7)] and TAH [35 days (32.0-38.0)] (Kruskal-Wallis test, p=0.373). There was a significant difference in direct cost (median, inter quartile range) between TAH [Rs.41943, (38256-44476)] versus TLH [50608 (46670-54859)], Mann-Whitney U test, p<0.001, NDVH [Rs.40373 (3693244212) versus TLH, Mann-Whitney U test, p<0.001. There was no significant difference between TAH and NDVH, Mann-Whitney U test, p=0.076. ICERTLH-TAH was Rs. 1733/ day compared to TAH. ICERNDVH-TAH was not calculated as both the cost and effect were more favourable than TAH. ICERTLH-NDVH was Rs.3412/day compared to NDVH. CONCLUSIONS: There was no significant difference in time to recover between TLH, NDVH and TAH. The optimum approach to hysterectomy appears to be NDVH in terms of costeffectiveness due to its lower cost, a fact that was suggested from the interim analysis presented at SLCOG sessions in 2017.