Same Day DischargeNCT04804826
Same Day Discharge Following Pelvic Reconstructive Surgery
An observational study of Same Day Discharge and Pelvic Organ Prolapse, run by TriHealth Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Same Day Discharge, Pelvic Organ Prolapse, Total Vaginal Hysterectomy
- What is being tested?
- Pelvic Reconstructive Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 6 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
About this study
Official title: Patient's Perceptions Regarding Same Day Discharge Following Pelvic Reconstructive Surgery: What do They Want Other Patients to Know?
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.
- Being tested
- Pelvic Reconstructive Surgery
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Reconstructive SurgeryProcedure or surgery
Pelvic Reconstructive Surgery including total vaginal hysterectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: Approximately 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start14 Jun 2021
- Primary completion5 Jan 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Same Day DischargeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Principal investigator, TriHealth - Cincinnati Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804826
- Sponsor's protocol ID
- 21-010
- Status last verified
- Feb 2024
- First submitted
- 16 Mar 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 29900817Evans 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Perceptions Regarding Same Day Discharge Following Pelvic Reconstructive Surgery: What do They Want Other Patients to Know?
- ClinicalTrials.gov ID
- NCT04804826
- Acronym / sponsor ID
- 21-010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Reconstructive SurgeryPelvic Reconstructive Surgery including total vaginal hysterectomy | Procedure or surgery | – |
Primary outcome
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."
1 secondary outcome
Number of subjects who satisfied with the results of the surgery
Time frame: Approximately 12 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 29900817Lloyd 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.
- Background: PubMed 31254524Evans 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Pauls, MD principal investigator
TriHealth - Cincinnati Urogynecology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Same Day Discharge and Pelvic Organ Prolapse, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who satisfied with the results of the surgery (time frame: Approximately 2 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04804826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.