Vault or Uterine prolapse surgery Evaluation – two parallel randomised controlled trials of surgical options for upper compartment (uterine or vault) pelvic organ prolapse (VUE)
Surgeons in forty UK hospitals will run two head-to-head trials to settle a long-running dispute about the best way to operate on pelvic organ prolapse—a condition where the womb or vaginal vault drops down, affecting hundreds of thousands of women. The uncertainty is costly. For women with uterine prolapse, surgeons disagree on whether to remove the womb or keep it in place. For those with vault prolapse (after a hysterectomy), the choice is between a vaginal or an abdominal suspension. Neither approach has clear evidence of superiority, so practice varies wildly across the NHS, and women may undergo unnecessary repeat surgery or suffer complications from a procedure that was not the best fit. If the trials succeed, they will produce the first robust, comparative data on both clinical outcomes and cost-effectiveness. The results will give surgeons and patients a clear, evidence-based choice—reducing the risk of failed repairs, cutting the number of repeat operations, and saving the NHS money by avoiding ineffective procedures. The economic model built from the trial data will also allow the health service to plan long-term, rather than relying on guesswork.
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Design: Two parallel randomised controlled trials (RCTs) of surgery for the treatment of women with upper compartment (uterine or vault) pelvic organ prolapse. Minimisation by key prognostic variables (type of prolapse, concomitant operation for incontinence or not, concomitant anterior and/or posterior prolapse operation or none, age and surgeon) will be included. Setting: Forty gynaecological surgery centres in UK hospitals. Target population: Women having upper compartment (uterine or vault) pelvic organ prolapse surgery. Health Technologies being assessed: (A) in women having uterine prolapse surgery: removal of the uterus versus uterine preservation; and (B) in women having vault prolapse surgery: vaginal vault suspension versus abdominal vault suspension. Measurement of costs and outcomes: Outcomes in both groups will be assessed by patient-completed questionnaires (using the Pelvic Organ Prolapse Symptom Score, POP-SS(1)) and clinician-observation of prolapse stage and type (using the POP-Q system (2)) at baseline (before surgery), and at 12 months after surgery, including identification of new prolapse types. Women will also complete a questionnaire at 6 months after surgery. Surgical procedures and complications will be recorded during the hospital stay using standard questionnaires. We will conform to the International Continence Society's recommendations for terminology and standard techniques for measuring outcomes. Consent will be sought for long term follow up but this will be funded separately. An economic evaluation will be an integral component of the study. The point of view adopted will be that of the NHS and the patient. Resource-use data collected will include the costs of the intervention and the use of other primary and secondary NHS services. Both health service costs and non-health service costs will be included, the latter collected from participants. Incremental cost-utility ratios will be computed comparing the interventions for each randomised comparison. The difference in utility will be expressed in terms of Quality Adjusted Life Years (QALYs) estimated from the responses to the EQ-5D. Using the best available data from the literature including the updated Cochrane review, an economic model will be developed that will extrapolate the findings of the study over a longer time horizon. This model will be developed in line with guidelines for best practice. Both the within trial and modelling economic evaluation will involve a deterministic and probabilistic sensitivity analysis to explore the impact of plausible sources of uncertainty. (1) Hagen S et al. Psychometric properties of the pelvic organ prolapse symptom score. BJOG: 2009; 116(1):25-31 (2) Bump RC et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. AMJOG: 1996; 175(1):10-17
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