Pelvic Organ ProlapseNCT04179955
Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse
An observational study of Pelvic Organ Prolapse, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult females undergoing sacrocolpopexy at Mayo Clinic Rochester
Who may be able to join
- 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
Who cannot join
- Repeat sacrocolpopexy
- Concurrent sling procedure
- Concurrent Pouch of Douglas repairs
- Concurrent anterior vaginal wall repairs
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative cost of surgery
Cost of surgery will be ascertained by summing marginal costs of surgery, including operative and anesthesia time, instruments and medications
Measured: SIx weeks postop
Patient Scar Assessment
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.
Measured: Six weeks postop
Secondary outcomes (6)
Surgical satisfaction
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.
Measured: Six weeks postop
Surgical satisfaction
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.
Measured: Six months postop
Urinary symptoms
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.
Measured: Six weeks postop
Urinary symptoms
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.
Measured: Six months postop
Sexual function
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.
Measured: Six months postop
Patient Scar Assessment
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.
Measured: Six months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start10 Dec 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuel Trabuco, Mayo Clinic
- Investigators
- Emanuel C Trabuco, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179955
- Sponsor's protocol ID
- 19-005064
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse
- ClinicalTrials.gov ID
- NCT04179955
- Acronym / sponsor ID
- 19-005064
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult females undergoing sacrocolpopexy at Mayo Clinic Rochester
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Repeat sacrocolpopexy
- Concurrent sling procedure
- Concurrent Pouch of Douglas repairs
- Concurrent anterior vaginal wall repairs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative cost of surgery
Time frame: SIx weeks postop
Cost of surgery will be ascertained by summing marginal costs of surgery, including operative and anesthesia time, instruments and medications
Patient Scar Assessment
Time frame: Six weeks 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.
6 secondary outcomes
Surgical satisfaction
Time frame: Six weeks postop
Surgical satisfaction
Time frame: Six months postop
Urinary symptoms
Time frame: Six weeks postop
Urinary symptoms
Time frame: Six months postop
Sexual function
Time frame: Six months postop
Patient Scar Assessment
Time frame: Six months postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Recruiting
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Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuel C Trabuco, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative cost of surgery (time frame: SIx weeks postop). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.