Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      The purpose of this study is to to determine if there is a difference in patient related
      outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse
      repair compared to robotic-assisted repair.

      We hypothesize that pain and quality of life following robotic-assisted repair will be
      similar to that following vaginal reconstruction, when performed in conjunction with vaginal
      hysterectomy.
    

Detailed description: 
      Since the introduction of the DaVinci robotic system (Intuitive Surgical, Sunnyvale, CA),
      there has been considerable debate regarding its use, cost-effectiveness, and subsequent
      impact on patient care. While some studies have examined surgical outcomes and analyzed costs
      of this technique compared to open, laparoscopic, and vaginal approaches, it remains unclear
      whether one route is superior.

      Indeed, data evaluating robotic-assisted and laparoscopic approaches to hysterectomy have
      shown similar patient results, but some reports note higher costs and longer operating times
      with robotics. Others suggest contrary information, with comparable surgical time, reduced
      blood loss, shorter hospital stay, and lower rate of conversion to laparotomy using
      robotic-assisted hysterectomy compared to laparoscopic or abdominal. Research contrasting
      robot-assisted laparoscopic myomectomy with abdominal myomectomy posit greater cost
      associated with the robotic procedure, but enhanced benefit of decreased blood loss,
      complication rates, and length of stay.

      However, these issues have not been explored in urogynecologic patients. A single study
      comparing robotic versus vaginal urogynecologic procedures in elderly women showed robotic
      surgery to be associated with fewer postoperative complications than the vaginal route.
      Nevertheless the procedures were not always performed in conjunction with hysterectomy, and
      the analysis was retrospective.

      In our practice, vaginal hysterectomy is the preferred method when correcting uterovaginal
      prolapse. We then address the reconstruction either vaginally or robotically. Vaginal repairs
      are comprised of the following: a vaginal vault suspension using the uterosacral ligaments,
      enterocele repair, anterior repair, and posterior/rectocele repair. The robotic procedure
      performed is a robotic sacral colpopexy using lightweight, polypropylene mesh, as well as a
      posterior/rectocele repair transvaginally. Both of these techniques are well-researched,
      effective approaches to addressing prolapse in a durable way. However, it is not clear
      whether one is superior in patient-related quality of life outcomes. We seek to compare
      patient quality of life by assessing differences in subjective impressions of pain following
      these procedures
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have been scheduled for a vaginal hysterectomy with either vaginal or
        robot-assisted prolapse repairs with Cincinnati Urogynecology Associates will be approached
        for participation in the study.

        Eligible subjects are patients of Cincinnati Urogynecology Associates, aged 18-90, planning
        to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic
        organ prolapse, as well as a posterior/rectocele repair, with or without a suburethral
        sling or ovarian removal. All subjects will undergo general anesthesia. Eligible subjects
        must be able to speak and read English, and be able to understand the informed consent
        statement.
      
Keywords: Quality of life; Robotic surgery; Vaginal surgery; Prolapse repair; Vaginal hysterectomy