Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?

Pelvic Organ Prolapse Clinical Trial

Official title: Is There a Difference in Pain and Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Compared to Robotic Colpopexy? A Prospective Cohort Study

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

• NCT number: NCT02049996
• Study type: Observational
• Source: TriHealth Inc.
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: June 2016