Same Day Discharge Following Pelvic Reconstructive Surgery

NCT ID: NCT04804826

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-14

Study Completion Date

2022-04-06

Brief Summary

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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

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Conditions

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Same Day Discharge Pelvic Organ Prolapse Total Vaginal Hysterectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pelvic Reconstructive Surgery

Pelvic Reconstructive Surgery including total vaginal hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Pauls, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth - Cincinnati Urogynecology Associates

Locations

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Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29900817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31254524 (View on PubMed)

Other Identifiers

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21-010

Identifier Type: -

Identifier Source: org_study_id

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