Same Day Discharge Following Pelvic Reconstructive Surgery

Completed

• Conditions: Total Vaginal Hysterectomy; Same Day Discharge; Pelvic Organ Prolapse

• Registration Number: NCT04804826
• Lead Sponsor: TriHealth Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-06-14
• Primary Completion: 2022-01-05
• Study Completion: 2022-04-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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."

Trial Locations

Locations (1)

Cincinnati Urogynecology Associates; 🇺🇸 Cincinnati, Ohio, United States