Pelvic Organ Prolapse Clinical Trial
Official title:
Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse
Verified date | June 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | May 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative cost of surgery | Cost of surgery will be ascertained by summing marginal costs of surgery, including operative and anesthesia time, instruments and medications | SIx weeks postop | |
Primary | 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. | Six weeks postop | |
Secondary | 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. | Six weeks postop | |
Secondary | 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. | Six months postop | |
Secondary | 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. | Six weeks postop | |
Secondary | 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. | Six months postop | |
Secondary | 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. | Six months postop | |
Secondary | 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. | Six months postop |
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