Cost-effectiveness Comparison Between Vaginal Versus Robotic Mesh Surgery for Apical Prolapse: Prospective, Cohort Study
Condition: Prolapse; Female
MeSH terms: Prolapse
Study type: Observational

Summary: 
      Cost-effectiveness, safety, outcomes and diagnostic development in advanced apical female
      genital prolapse reconstructive surgery by vaginal and robotic-assisted mesh surgery.

      A multicenter, prospective, parallel, cohort, comparative study between the vaginal and
      robotic-assisted mesh surgery including 200 patients.
    

Detailed description: 
      Pelvic organ prolapse (POP) is a common condition and may be disabling and limiting quality
      of life (QoL) among aging women. POP may arise in the anterior (cystocele), posterior
      (rectocele) and middle compartment (apical POP) of the vagina. Apical POP includes descent of
      uterus or vaginal vault (if uterus was previously removed). The lifetime risk of undergoing a
      single operation for POP or urinary incontinence by age 80 is 11%. In Sweden, the risk to
      undergo 2 pelvic floor surgery is about 130 000 women. Traditional Surgical repairs of POP
      using native connective tissues are commonly used but the risk for POP recurrence is high if
      apical prolapse is present (ca 60%). Thus, minimal invasive surgical approaches by apical
      trans-vaginal mesh (A-TVM) and robotic sacral colpopexy (RSC) to support the vaginal apex
      (middle compartment) are in progress. 1 Evidence show effectivity and improved QoL after
      surgery.

      Vaginal and robotic accesses may be available to many patients. Vaginal approach may allow
      surgeon to perform surgery for all POP compartments and perineal injury in one single surgery
      opportunity. Contra-indications for general anesthesia and some abdominal diseases or
      conditions may dismiss the robotic surgery. In contrast, all patients can be operated via the
      vaginal approach except for patient unwellness. Thus, a direct low cost of vaginal surgery
      may be possible. In the other hand, costs for robotic surgery are high. Whether or not this
      may be reflected on cost-effectiveness based on QoL improvement after surgery has not yet
      been studied.

      Visualising synthetic implants i.e. POP mesh and the Tension-Free Vaginal Tape (TVT) implant
      for urinary incontinence (UI) by ultrasonography (US) has been a subject for some studies.
      Using US, localisation of the TVT in correlation to urinary bladder neck and how close to
      urethra may explain outcomes after TVT surgery. Given its importance, knowledge of how mesh
      anatomical position may influence outcomes, it may be useful in further POP surgery
      development. Our results indicate that US can be used and is reproducible in mapping of A-TVM
      (manuscript).

      Growing need worldwide is to have more cost-effective and safe health care.
      Cost-effectiveness, safety, outcomes, POP-recurrence and effects on pelvic floor dysfunction
      have not yet been directly compared between vaginal and robotic mesh surgery for apical POP.

      Topic: Cost-Effectiveness (Vaginal vs robotic POP mesh surgery), QoL, safety and outcomes.
    

Intervention name(s): Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific
Intervention type(s): Device
Intervention description(s): Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy
Other intervention name(s): Robotic: Artisyn® Y-Shaped Mesh - Ethicon
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with apical prolapse and suffering prolapse symptoms.