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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