Same Day Discharge Following Pelvic Reconstructive Surgery

NCT04804826 | Completed

• 1 other identifier: 21-010
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Same Day Discharge; Pelvic Organ Prolapse; Total Vaginal Hysterectomy

Outcome Measures

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."

  Approximately 2 weeks postoperatively

Secondary Outcomes (1)

• Number of subjects who satisfied with the results of the surgery

  Approximately 12 weeks postoperatively

Interventions

Pelvic Reconstructive Surgery PROCEDURE

Pelvic Reconstructive Surgery including total vaginal hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Related Publications (2)

• 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.

  PMID: 29900817 BACKGROUND

• 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.

  PMID: 31254524 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: June 14, 2021
• Primary Completion: January 5, 2022
• Study Completion: April 6, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

US (1)