Cost-effectiveness of TLH versus NDVH versus TAH: a multi-centre randomized controlled trial.

Abstract

OBJECTIVE: Hysterectomy is the commonest major gynaecological surgical procedure. There are many approaches in performing a hysterectomy which depend on clinical criteria. However certain patients are suitable to be operated through any approach. The objective of this study was to provide evidence on the optimal approach in terms of cost-effectiveness between non-descent vaginal hysterectomy (NDVH), total laparoscopic hysterectomy (TLH) and total abdominal hysterectomy (TAH). METHODS: A multi-centre three arm randomized controlled trial is being conducted at the professorial gynaecology unit, North Colombo Teaching Hospital, Ragama and gynaecology unit, District General Hospital, Mannar. Results of the Mannar arm are presented. Study population were women needing hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus 14 weeks, previous pelvic surgery, those requiring incontinence/pelvic floor surgery, co-morbidities which precludes laparoscopic surgery and women who are illiterate. Primary outcome was time taken to resume all activities done prior to surgery. A micro-costing approach was adopted to calculate utilization of hospital resources from the time of presentation to the gynaecology clinic up to six months after surgery. The treatment groups were compared using a one-way analysis of variance (ANOVA) followed by Tukey's HSD for post hoc comparisons of the mean values. Incremental cost-effectiveness 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: There was a significant difference in time to recover in TLH [28.9 days (26.2-31.2), p<0.02] and NDVH [29.8 days (26.8-32.9), p<0.05] versus TAH [35.5 days (32.0-39.0)]. There was no significant difference between TAH and NDVH [p=0.90].The direct cost of a TLH [Rs. 45371 (43770-46972)] was significantly more than TAH [Rs. 34060 (32521-35599), p<0.001] or NDVH [Rs. 33038 (29720-36356), p<0.001]. There was no significant difference between TAH and NDVH (p=0.81). The incremental costs of a TLH was significantly more than TAH [Rs.11311 (9710 to 12912), p<0.001]. The incremental cost of a NDVH was [Rs. 1022(-4340 to 2296), p=0.81) less than TAH. ICER-TLH was Rs.1714/day. As both the cost as well as the time to recover was more favourable than TAH, ICER-NDVH was not calculated. CONCLUSION: This interim analysis shows that TLH and NDVH have a faster recovery compared to TAH. However, the incremental costs for a TLH were considerably higher. The optimum approach to hysterectomy appears to be NDVH in terms of cost-effectiveness