Clinical trial NCT04179955: Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse
Official title: Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Organ Prolapse
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females undergoing sacrocolpopexy at Mayo Clinic Rochester

Brief summary: Robotic sacrocolpopexy (a procedure for female pelvic organ prolapse) has been demonstrated to have equivalent surgical outcomes to open abdominal sacrocolpopexy and has been previously deemed more cost effective due to the longer hospital course following open procedures. The total cost of these procedures, including all costs of hospitalization as well as costs associated with the 30 days following surgery have previously been evaluated by the investigators. However, previous research is lacking in both the specific cost components that contribute to intraoperative cost of surgery as well as the patient perceived outcomes following these two procedures. This project aims to evaluate the marginal costs of surgery and to survey sacrocolpopexy patients to evaluate their satisfaction with outcomes and surgical scars.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Women ≥ 18 years of age
* Undergoing abdominal or robotic sacrocolpopexy with or without posterior vaginal repairs
* Willing and able to provide signed informed research consent
* Concurrent and prior hysterectomy

Exclusion Criteria:

* Repeat sacrocolpopexy
* Concurrent sling procedure
* Concurrent Pouch of Douglas repairs
* Concurrent anterior vaginal wall repairs

Primary outcomes:
measure: Intraoperative cost of surgery
timeFrame: SIx weeks postop
measure: Patient Scar Assessment
timeFrame: Six weeks postop
Secondary outcomes:
measure: Surgical satisfaction
timeFrame: Six weeks postop
measure: Surgical satisfaction
timeFrame: Six months postop
measure: Urinary symptoms
timeFrame: Six weeks postop
measure: Urinary symptoms
timeFrame: Six months postop
measure: Sexual function
timeFrame: Six months postop
measure: Patient Scar Assessment
timeFrame: Six months postop
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Emanuel C Trabuco, M.D.
role: PRINCIPAL_INVESTIGATOR
References: