- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04179955
Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative cost of surgery
Time Frame: SIx weeks postop
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Cost of surgery will be ascertained by summing marginal costs of surgery, including operative and anesthesia time, instruments and medications
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SIx weeks postop
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Patient Scar Assessment
Time Frame: Six weeks postop
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Patient satisfaction with their surgical scars from sacrocolpopexy will be assessed via the Patient Scar Assessment Survey (POSAS).
This validated scar assessment scale ranges from 6 to 60, with higher scores indicating worse scar aesthetics and symptoms.
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Six weeks postop
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical satisfaction
Time Frame: Six weeks postop
|
Patient satisfaction with surgery will be assessed via the Surgical Satisfaction Questionnaire(SSQ-8), a validated survey for surgical satisfaction.
Scores range from 0 to 100, with higher scores denoting better surgical satisfaction.
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Six weeks postop
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Surgical satisfaction
Time Frame: Six months postop
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Patient satisfaction with surgery will be assessed via the Surgical Satisfaction Questionnaire(SSQ-8), a validated survey for surgical satisfaction.
Scores range from 0 to 100, with higher scores denoting better surgical satisfaction.
|
Six months postop
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Urinary symptoms
Time Frame: Six weeks postop
|
Patient urinary symptoms will be compared preoperatively with postoperative scores via the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI), a validated survey for female urinary symptoms.
Scores range from 0 to 21, with higher scores indicating more urinary distress/dysfunction.
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Six weeks postop
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Urinary symptoms
Time Frame: Six months postop
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Patient urinary symptoms will be compared preoperatively with postoperative scores via the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI), a validated survey for female urinary symptoms.
Scores range from 0 to 21, with higher scores indicating more urinary distress/dysfunction.
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Six months postop
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Sexual function
Time Frame: Six months postop
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Patient sexual function will be compared preoperatively with postoperative scores via the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), a survey for female sexual function.
Scores range from 0 to 48, with higher scores indicating better sexual function.
|
Six months postop
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Patient Scar Assessment
Time Frame: Six months postop
|
Patient satisfaction with their surgical scars from sacrocolpopexy will be assessed via the Patient Scar Assessment Survey (POSAS).
This validated scar assessment scale ranges from 6 to 60, with higher scores indicating worse scar aesthetics and symptoms.
|
Six months postop
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emanuel C Trabuco, M.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-005064
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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