HysterectomyNCT03610425
A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery
An observational study of Hysterectomy, run by HonorHealth Research Institute at 1 site in United States.
Trial summary
Difference in outcome measures with the addition of post-operative evidence based bundle pre-operative education compared to standard pre-operative education given to patients prior to hysterectomy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2017to 28 Feb 2018
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.
Who may be able to join
- Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
HonorHealth Scottsdale Thompson Peak
Scottsdale, Arizona, 85255
About this study
Difference in outcome measures with the addition of post-operative evidence based bundle pre-operative education compared to standard pre-operative education given to patients prior to hysterectomy.
Read the detailed description
The purpose of this project is to evaluate whether there is a difference in outcome measures (length of stay, occurrence of readmission, and patient satisfaction) with the addition of a post-operative evidence-based bundle/standard pre-operative education compared to standard pre-operative education alone that is given to patients prior to a hysterectomy (open, vaginal, or laparoscopic).
- Conditions
- Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-op evidence based bundle w/ Pre-op education | 25 patients undergoing hysterectomy from October 1, 2017 to December 31, 2017 will receive the post-operative evidence based bundle/standard pre-operative education. | |
| Standard pre-operative education alone | 25 patients undergoing hysterectomy from October 1, 2017 to December 31, 2017 will receive the standard pre-operative education alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Number of days spent in the hospital from the first post-operative day to the day of discharge
Measured: 0 to 30 days
Occurrence of Re-Admission
Re-admission within 30 days will be measured through the EMR
Measured: 0 to 30 days
Patient Satisfaction
Patient Satisfaction Survey that consists of 7 questions utilizing a likert scale from excellent to poor
Measured: 0 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start17 Oct 2017
- Primary completion19 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610425
- Sponsor's protocol ID
- 1088437
- Status last verified
- Jul 2018
- First submitted
- 26 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery
- ClinicalTrials.gov ID
- NCT03610425
- Acronym / sponsor ID
- 1088437
- Conditions
- Hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 1 Aug 2018 (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.
Difference in outcome measures with the addition of post-operative evidence based bundle pre-operative education compared to standard pre-operative education given to patients prior to hysterectomy.
Detailed description
The purpose of this project is to evaluate whether there is a difference in outcome measures (length of stay, occurrence of readmission, and patient satisfaction) with the addition of a post-operative evidence-based bundle/standard pre-operative education compared to standard pre-operative education alone that is given to patients prior to a hysterectomy (open, vaginal, or laparoscopic).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-op evidence based bundle w/ Pre-op education | – | –25 patients undergoing hysterectomy from October 1, 2017 to December 31, 2017 will receive the post-operative evidence based bundle/standard pre-operative education. |
| Standard pre-operative education alone | – | –25 patients undergoing hysterectomy from October 1, 2017 to December 31, 2017 will receive the standard pre-operative education alone. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.
Key inclusion criteria (1 listed)
- Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of Stay
Time frame: 0 to 30 days
Number of days spent in the hospital from the first post-operative day to the day of discharge
Occurrence of Re-Admission
Time frame: 0 to 30 days
Re-admission within 30 days will be measured through the EMR
Patient Satisfaction
Time frame: 0 to 30 days
Patient Satisfaction Survey that consists of 7 questions utilizing a likert scale from excellent to poor
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 1 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hysterectomy, run by HonorHealth Research Institute 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 1 inclusion and 0 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 1 Aug 2018. 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?
Length of Stay (time frame: 0 to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2018; AzTrials last refreshed its copy on 27 Oct 2026.