Same Day Discharge Following Pelvic Reconstructive Surgery

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804826
• Other study ID #: 21-010
• Status: Completed
• Start date: June 14, 2021
• Est. completion date: April 6, 2022

Study information

• Verified date: February 2024
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 6, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Pelvic Reconstructive Surgery
Pelvic Reconstructive Surgery including total vaginal hysterectomy

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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