Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pelvic Organ Prolapse
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Abdominal sacrocolpopexy (ASC) is the gold standard operation to treat pelvic organ prolapse. The open approach has been associated with prolonged hospital stay and higher peri-operative morbidity, leading many providers to prefer a robotic approach. Even though robotic ASC overcomes many of the tec...

Abdominal sacrocolpopexy (ASC) is the gold standard operation to treat pelvic organ prolapse. The open approach has been associated with prolonged hospital stay and higher peri-operative morbidity, leading many providers to prefer a robotic approach. Even though robotic ASC overcomes many of the technical hurdles associated with laparoscopy, it is expensive, and it achieves cost effectiveness compared to open only because of large discrepancies in length of stay. Preliminary data at our institution suggests that with the introduction of ERAS, decreases in hospital stay after abdominal surgery have driven down the discrepancy in length of stay between open (1.8 days) and robotic (1.4 days) ASC. Previous analysis accounted for differences in OR time as well as postoperative stay. However, this cost data is obtained from data on billed charges rather than a summation of actual costs sustained; data on specific incurred costs is scant in the literature. Robotic surgery requires equipment and resources which also increase the price of the procedure. Specifically, Da Vinci robots are priced at $1.4 million, require $120,000 in annual maintenance contracts, and the cost of disposable instruments can reach $2000 per case. Instruments and disposable materials, while contracted at Mayo, do have published prices that may be used to better quantify intraoperative procedural costs. In addition to questions about the cost effectiveness of robotic versus abdominal sacrocolpopexy, data on patient satisfaction comparing the two procedures is minimal. While abdominal and robotic approaches have similar efficacy, patient perceived equivalence has been largely assumed. Additionally, the literature frequently lists improved cosmesis as a benefit to robotic surgery, yet the studies on scar satisfaction between the two approaches are lacking. Hypothesis: Intraoperative costs of abdominal sacrocolpopexy are significantly less than those in the robotic approach. However, patients who undergo robotic sacrocolpopexy have improved scar satisfaction and equivalent perceived surgical satisfaction. This is a prospective cohort study of intraoperative time and materials in open versus robotic ASC.

Tracking Information

NCT #
NCT04179955
Collaborators
Not Provided
Investigators
Principal Investigator: Emanuel C Trabuco, M.D. Mayo Clinic Study Chair: Mary V. Baker, M.D. Mayo Clinic