Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04059328
Collaborator
(none)
7
1
7
30.4
Study Details
Study Description
Brief 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. The researchers then asked the physicians their opinion of the checklists.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
7 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Use of Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti: Utility in Bending the Learning Curve for Global Programs
Actual Study Start Date
:
Sep 29, 2018
Actual Primary Completion Date
:
Oct 6, 2018
Actual Study Completion Date
:
Oct 6, 2018
Arms and Interventions
| Arm | 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. |
Procedure: Surgical training
This was a gyn laparoscopy training and simulation course
|
Outcome Measures
Primary Outcome Measures
- Number of physicians that reported favoring the checklist greater than 3 on a likert scale of 1-5. [1 week]
Likert scale 1-5. 5 indicates highest satisfaction with the checklist.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- OBGYN physician in Haiti
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital at Mirebalais | Mirebalais | Haiti |
Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
- Principal Investigator: Lara Harvey, MD MPH, Vanderbilt University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lara Harvey,
Assistant Professor,
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT04059328
Other Study ID Numbers:
- 181435
First Posted:
Aug 16, 2019
Last Update Posted:
Aug 30, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No