NCT04059328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2018

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

7 days

First QC Date

August 14, 2019

Last Update Submit

August 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week

Study Arms (1)

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

Interventions

This was a gyn laparoscopy training and simulation course

Physicians in Haiti

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

OBGYN attendings and residents practicing at University Hospital of Mirebalais

You may qualify if:

  • OBGYN physician in Haiti

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital at Mirebalais

Mirebalais, Haiti

Location

Study Officials

  • Lara Harvey, MD MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 16, 2019

Study Start

September 29, 2018

Primary Completion

October 6, 2018

Study Completion

October 6, 2018

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations