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OpenTrials
Completed

NCT Number: NCT04804826

Same Day Discharge Following Pelvic Reconstructive Surgery

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pelvic Reconstructive Surgery

Procedure

Pelvic Reconstructive Surgery including total vaginal hysterectomy

Primary outcomes

  1. Number of subjects who satisfied with the results of the surgery

    Time frame: 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 outcomes

  1. Number of subjects who satisfied with the results of the surgery

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2021
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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