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Predictors of Recovery Expectancy

Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT04274491
Collaborator
(none)
202
Enrollment
1
Location
23.1
Actual Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    202 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predictors of Recovery Expectancy After Surgery for Pelvic Organ Prolapse
    Actual Study Start Date :
    Mar 1, 2020
    Actual Primary Completion Date :
    Jan 1, 2022
    Actual Study Completion Date :
    Feb 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Pelvic Organ Prolapse Surgery Patients

    Participants with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery will be recruited. Participants will be asked to complete a preoperative online survey regarding their health, recovery expectancy, and different roles. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery

    Outcome Measures

    Primary Outcome Measures

    1. Recovery Expectancy [Participant will complete preoperative survey at 1 day (once surgery is scheduled).]

      Expectation that recovery from surgery will be greater than 6 weeks from 0 to 100 percent where 100% indicates complete recovery within 6 weeks

    Secondary Outcome Measures

    1. Post Discharge Recovery [Questionnaire will be completed on post op day #14]

      Postdischarge Surgical Recovery Scale 13 which is validated tool for measuring postoperative recovery

    2. Post Discharge Recovery [Questionnaire will be completed on post op day #42]

      Postdischarge Surgical Recovery Scale 13 which is validated tool for measuring postoperative recovery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Urogynecology Indianapolis Indiana United States 46032

    Sponsors and Collaborators

    • Indiana University

    Investigators

    • Principal Investigator: Michael Heit, MD, Indiana University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrew Doering, Co Principal Investigator, Indiana University
    ClinicalTrials.gov Identifier:
    NCT04274491
    Other Study ID Numbers:
    • 2001849013
    First Posted:
    Feb 18, 2020
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andrew Doering, Co Principal Investigator, Indiana University
    Recovery
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Mar 31, 2022