- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059328
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
August 28, 2019 updated by: Lara Harvey, Vanderbilt University Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
7
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mirebalais, Haiti
- University Hospital at Mirebalais
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
OBGYN attendings and residents practicing at University Hospital of Mirebalais
Description
Inclusion Criteria:
- OBGYN physician in Haiti
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
This was a gyn laparoscopy training and simulation course
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lara Harvey, MD MPH, Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2018
Primary Completion (Actual)
October 6, 2018
Study Completion (Actual)
October 6, 2018
Study Registration Dates
First Submitted
August 14, 2019
First Submitted That Met QC Criteria
August 15, 2019
First Posted (Actual)
August 16, 2019
Study Record Updates
Last Update Posted (Actual)
August 30, 2019
Last Update Submitted That Met QC Criteria
August 28, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 181435
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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