Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse

NCT04179955 | Active Not Recruiting

• 1 other identifier: 19-005064
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Surgical satisfaction

  Six weeks postop

• Surgical satisfaction

  Six months postop

• Urinary symptoms

  Six weeks postop

• Urinary symptoms

  Six months postop

• Sexual function

  Six months postop

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females only as this involves surgery for pelvic organ prolapse.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult females undergoing sacrocolpopexy at Mayo Clinic Rochester

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Emanuel C Trabuco, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: December 10, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)