GynecologyNCT04059328
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
An observational study of Gynecology and Surgery, run by Vanderbilt University Medical Center at 1 site in Haiti.
Trial summary
The researchers traveled to University Hospital Mirebalais in Haiti and provided a one week long laparoscopic training and simulation course to the 7 OBGYN faculty there. The researchers used novel checklists to help the faculty to set up for laparoscopic cases and care for the equipment needed. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gynecology, Surgery
- What is being tested?
- Surgical training
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteHaiti
- Study dates
- 29 Sep 2018to 6 Oct 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: OBGYN attendings and residents practicing at University Hospital of Mirebalais
Who may be able to join
- OBGYN physician in Haiti
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti: Utility in Bending the Learning Curve for Global Programs
The researchers traveled to University Hospital Mirebalais in Haiti and provided a one week long laparoscopic training and simulation course to the 7 OBGYN faculty there. The researchers used novel checklists to help the faculty to set up for laparoscopic cases and care for the equipment needed. The researchers then asked the physicians their opinion of the checklists.
- Conditions
- Gynecology, Surgery
- Being tested
- Surgical training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical trainingProcedure or surgery
This was a gyn laparoscopy training and simulation course
| Study group | Role | What they receive |
|---|---|---|
| Physicians in Haiti | 7 OBGYN physicians underwent a laparoscopic training and simulation course and then were proctored as they performed 3 in vivo cases using a check list to help the participants remember all the steps of laparoscopic set-up. Receives: Procedure: Surgical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of physicians that reported favoring the checklist greater than 3 on a likert scale of 1-5.
Likert scale 1-5. 5 indicates highest satisfaction with the checklist.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start29 Sep 2018
- Primary completion6 Oct 2018
- Study completion6 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecologyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Harvey, Vanderbilt University Medical Center
- Investigators
- Lara Harvey, MD MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059328
- Sponsor's protocol ID
- 181435
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti: Utility in Bending the Learning Curve for Global Programs
- ClinicalTrials.gov ID
- NCT04059328
- Acronym / sponsor ID
- 181435
- Conditions
- Gynecology, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 29 Sep 2018 (actual)
- Primary completion
- 6 Oct 2018 (actual)
- Study completion
- 6 Oct 2018 (actual)
- First posted
- 16 Aug 2019 (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.
The researchers traveled to University Hospital Mirebalais in Haiti and provided a one week long laparoscopic training and simulation course to the 7 OBGYN faculty there. The researchers used novel checklists to help the faculty to set up for laparoscopic cases and care for the equipment needed. The researchers then asked the physicians their opinion of the checklists.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians in Haiti | – | Procedure: Surgical training7 OBGYN physicians underwent a laparoscopic training and simulation course and then were proctored as they performed 3 in vivo cases using a check list to help the participants remember all the steps of laparoscopic set-up. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- OBGYN attendings and residents practicing at University Hospital of Mirebalais
Key inclusion criteria (1 listed)
- OBGYN physician in Haiti
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Surgical trainingThis was a gyn laparoscopy training and simulation course | Procedure or surgery | Physicians in Haiti |
Primary outcome
Number of physicians that reported favoring the checklist greater than 3 on a likert scale of 1-5.
Time frame: 1 week
Likert scale 1-5. 5 indicates highest satisfaction with the checklist.
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 30 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Lara Harvey, MD MPH principal investigator
Vanderbilt University Medical Center
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 Gynecology and Surgery, run by Vanderbilt University Medical Center at 1 site in Haiti.
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 1 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 30 Aug 2019. 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 Haiti. 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 physicians that reported favoring the checklist greater than 3 on a likert scale of 1-5. (time frame: 1 week). 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 30 Aug 2019.