Same Day Discharge Following Pelvic Reconstructive Surgery

Patient's Perceptions Regarding Same Day Discharge Following Pelvic Reconstructive Surgery: What do They Want Other Patients to Know?

This is a prospective cross-sectional study in which patients undergoing major pelvic reconstructive surgery with total vaginal hysterectomy will be recruited and enrolled. At approximately 2 weeks and 12 weeks postoperatively, enrolled patients will be asked to complete a survey detailing their experience with SDD, surgical recovery, and advice for prospective patients.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Same Day Discharge; Total Vaginal Hysterectomy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent a total vaginal hysterectomy with concurrent vaginal native tissue prolapse repairs, including an apical suspension procedure performed by one of the fellowship trained urogynecologists at TriHealth.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects who satisfied with the results of the surgery	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."	Approximately 2 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects who satisfied with the results of the surgery	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."	Approximately 12 weeks postoperatively

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Rachel Pauls, MD, TriHealth - Cincinnati Urogynecology Associates

Publications and helpful links

General Publications

• Lloyd JC, Guzman-Negron J, Goldman HB. Feasibility of same day discharge after robotic assisted pelvic floor reconstruction. Can J Urol. 2018 Jun;25(3):9307-9312.
• Evans S, Myers EM, Vilasagar S. Patient perceptions of same-day discharge after minimally invasive gynecologic and pelvic reconstructive surgery. Am J Obstet Gynecol. 2019 Dec;221(6):621.e1-621.e7. doi: 10.1016/j.ajog.2019.06.046. Epub 2019 Jun 27.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): January 5, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 21-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No