CClinicalTrials.gg
CompletedNCT04804826Updated Feb 5, 2024

Same Day Discharge Following Pelvic Reconstructive Surgery

An observational study in Same Day Discharge, Pelvic Organ Prolapse and Total Vaginal Hysterectomy, sponsored by TriHealth Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by TriHealth Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Same Day Discharge
  • Pelvic Organ Prolapse
  • Total Vaginal Hysterectomy
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In context

Prolapse

676 studies on the registry are indexed under Prolapse; 79 are open to participants now.

This study's enrollment of 54 is below the median of 126 across 222 observational studies indexed under Prolapse.

Browse Prolapse studies →

Lead sponsor

TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (actual)
Patient registry
No

Interventions

  • ProcedurePelvic Reconstructive Surgery

    Pelvic Reconstructive Surgery including total vaginal hysterectomy

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What researchers measure

Primary outcomes

  1. 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."

    Time frame: Approximately 2 weeks postoperatively

Secondary outcomes

  1. 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."

    Time frame: Approximately 12 weeks postoperatively

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Study locations

1 site
  • Cincinnati Urogynecology Associates
    Cincinnati, Ohio 45220, United States
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References and documents

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. PubMed 29900817 ↗
  • 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. PubMed 31254524 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04804826
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
Mar 18, 2021
Start date
Jun 14, 2021
Primary completion
Jan 5, 2022
Completion
Apr 6, 2022
Last update
Feb 5, 2024

Study contacts

Rachel Pauls, MD
principal investigator · TriHealth - Cincinnati Urogynecology Associates

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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