A Study of Opioid Prescribing Patterns in a Female Pelvic Surgery Practice
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-004658
Sponsor Protocol Number: 17-004658
About this study
The objective for this study is to learn more about the opioid prescribing patterns in the Division of Urogynecology (Department of Obstetrics and Gynecology) at our institution for pelvic organ prolapse surgery (both abdominal and vaginal routes) and isolated synthetic midurethral sling placements.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Female patients:
- Older than 18 years of age
- Who are opioid naïve (defined as no history of opioid use within 30 days prior to their procedure
- Undergoing reconstructive surgery for pelvic organ prolapse (vaginal, abdominal, or robotic), with or without concomitant anti-incontinence OR isolated synthetic midurethral sling placement
- Who understand and have signed written informed consent for the study
Exclusion Criteria:
Patients that:
- Have opioid use within 30 days prior to their procedure
- Have complications requiring readmission or return to the operating room within 30 days of their index procedure
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Gebhart, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available