Surgery Clinical Trial
Official title:
Predictors of Recovery Expectancy After Surgery for Pelvic Organ Prolapse
NCT number | NCT04274491 |
Other study ID # | 2001849013 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | February 1, 2022 |
Verified date | March 2022 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to identify factors that influence a person's expectations regarding recovery from pelvic organ prolapse surgery. This is important because a person's expectations regarding recovery from surgery help to predict how a person will actually recover. Our hypothesis is that women with multiple roles will have expectations of a longer surgical recovery time after surgery for pelvic organ prolapse after controlling for known predictors of recovery expectancies. Participants will complete a preoperative online survey. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery.
Status | Completed |
Enrollment | 202 |
Est. completion date | February 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery. - English speaking. - Over the age of 18. - Use email as a form of communication. - Have a reliable internet connection at home. - Have a computer/smartphone/tablet at home. Exclusion Criteria: - Non English speaking patients - Patients without active email. - Patients without access to reliable internet connection. - Patients without access to computer/smartphone/tablet. - Patients with less than stage II prolapse. |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Urogynecology | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recovery Expectancy | Expectation that recovery from surgery will be greater than 6 weeks from 0 to 100 percent where 100% indicates complete recovery within 6 weeks | Participant will complete preoperative survey at 1 day (once surgery is scheduled). | |
Secondary | Post Discharge Recovery | Postdischarge Surgical Recovery Scale 13 which is validated tool for measuring postoperative recovery | Questionnaire will be completed on post op day #14 | |
Secondary | Post Discharge Recovery | Postdischarge Surgical Recovery Scale 13 which is validated tool for measuring postoperative recovery | Questionnaire will be completed on post op day #42 |
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