Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: Study protocol for a randomized controlled trial

Background: Hysterectomy is the commonest major gynaecological surgery. Although there are many approaches to hysterectomy, which depend on clinical criteria, certain patients may be eligible to be operated in any of the several available approaches. However, most comparative studies on hysterectomy are between two approaches. There is also a relative absence of data on long-term outcomes on quality of life and pelvic organ function. There is no single study which has considered quality of life, pelvic organ function and cost-effectiveness for the three main types of hysterectomy. Therefore, the objective of this study is to provide evidence on the optimal route of hysterectomy in terms of cost-effectiveness by way of a three-armed randomized control study between non-descent vaginal hysterectomy, total laparoscopic hysterectomy and total abdominal hysterectomy. Methods: A multicentre three-armed randomized control trial is being conducted at the professorial gynaecology unit of the North Colombo Teaching Hospital, Ragama, Sri Lanka and gynaecology unit of the District General Hospital, Mannar, Sri Lanka. The study population is women needing hysterectomy for non-malignant uterine causes. Patients with a uterus > 14 weeks, previous pelvic surgery, those requiring incontinence surgery or pelvic floor surgery, any medical illness which caution/contraindicate laparoscopic surgery and who cannot read and write will be excluded. The main exposure variable is non-descent vaginal hysterectomy and total laparoscopic hysterectomy. The control group will be patients undergoing total abdominal hysterectomy. The primary outcome is time to recover following surgery, which is the earliest time to resume all of the usual activities done prior to surgery. In total, 147 patients (49 per arm) are needed to have 80% power at α-0.01 considering a loss to follow-up of 20% to detect a 7-day difference between the three routes; TLH versus TAH versus NDVH. The economic evaluation will take a societal perspective and will include direct costs in relation to allocation of healthcare resources and indirect costs which are borne by the patient. A micro-costing approach will be adopted to calculate direct costs from the time of presentation to the gynaecology clinic up to 6 months after surgery. Incremental cost-effectiveness ratios (ICER) will be obtained by calculating the incremental costs divided by the incremental effects (time to recover and QALYs gained) for the intervention groups (NDVH and TLH) over the standard care (TAH) group. Discussion: The cost of the procedure, quality of life and pelvic organ function following the three main routes of hysterectomy are important to clinicians and healthcare providers, both in developed and developing countries. Trial registration: The study was registered in the Sri Lanka clinical trials registry (SLCTR/2016/020) and the International Clinical Trials Registry Platform ( U1111-1194-8422) on 26 July 2016.