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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Indiana University Urogynecology Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

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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