Same Day Discharge Following Pelvic Reconstructive Surgery

Sponsor
TriHealth Inc. (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04804826
Collaborator
(none)
50
1
19
2.6

Study Details

Study Description

Brief Summary

This is a prospective cross-sectional study to describe patients' perceptions and experience regarding same day discharge following pelvic reconstructive surgery including total vaginal hysterectomy, in order to improve future patient counseling and expectations.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pelvic Reconstructive Surgery

Detailed Description

In response to COVID-19, the urogynecology department at TriHealth has recently transitioned to a same day discharge (SDD) model for our major pelvic reconstruction surgeries with total vaginal hysterectomy. Traditionally, these patients were admitted for overnight observation and discharged to home on postoperative day one. SDD after major pelvic reconstructive surgery is new in our department, but multiple studies have shown that SDD after hysterectomy is safe, cost effective, and well received by patients.

While patients have been accepting of SDD, they often have questions in the preoperative period about what to expect once they are discharged home. Previous research has shown that patients appreciate advice and recommendations from others who have previously had the same surgery; often reporting improved outcomes and satisfaction. Direct advice and narrative stories from other patients can provide a "more personal" experience of the day-to-day coping postoperatively that the physician cannot necessarily provide.

We would like to get our patients' perspective on what happened immediately after surgery, in the hospital and at home. By expanding our awareness as providers of what challenges patients face upon discharge, we will be better able to counsel patients in the preoperative period, improve patient satisfaction with surgery and SDD, and help develop strategies to mitigate areas of concern regarding the surgical process.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patient's Perceptions Regarding Same Day Discharge Following Pelvic Reconstructive Surgery: What do They Want Other Patients to Know?
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Number of subjects who satisfied with the results of the surgery [Approximately 2 weeks postoperatively]

    Number of subjects who answered either "Very Satisfied" or "Satisfied" to a Likert scale question "How satisfied are you with the results of your surgery." The liker scale choices are "Very Satisfied", "Satisfied", "Neutral", "Unsatisfied", and "Very Unsatisfied."

Secondary Outcome Measures

  1. Number of subjects who satisfied with the results of the surgery [Approximately 12 weeks postoperatively]

    Number of subjects who answered either "Very Satisfied" or "Satisfied" to a Likert scale question "How satisfied are you with the results of your surgery." The liker scale choices are "Very Satisfied", "Satisfied", "Neutral", "Unsatisfied", and "Very Unsatisfied."

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy

  • Apical repair with uterosacral ligament suspension or sacrospinous ligament fixation

  • They may also have any of the following concurrent procedures: Anterior repair, Posterior repair, Enterocele repair, Suburethral sling for incontinence

  • Surgery by one of the fellowship trained urogynecologists at TriHealth

  • English speaking

Exclusion Criteria:
  • Enrollment in the "Diazepam Research Study" (Protocol ID:19-130)

  • Concomitant procedure with another surgeon

  • Chronic pain conditions that require daily use of narcotic pain medications (including but not limited to: chronic back or pelvic pain, interstitial cystitis, fibromyalgia)

  • Concomitant anal sphincteroplasty, mesh removal or use of mesh for prolapse (excluding sling procedures)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cincinnati Urogynecology Associates Cincinnati Ohio United States 45220

Sponsors and Collaborators

  • TriHealth Inc.

Investigators

  • Principal Investigator: Rachel Pauls, MD, TriHealth - Cincinnati Urogynecology Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT04804826
Other Study ID Numbers:
  • 21-010
First Posted:
Mar 18, 2021
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2021