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CompletedNCT04059328Updated Aug 30, 2019

Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti

An observational study in Gynecology and Surgery, sponsored by Vanderbilt University Medical Center. Completed at 1 site in Haiti. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
7
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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Conditions studied

  • Gynecology
  • Surgery
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In context

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 159 are open to participants now.

Of its 124 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

OBGYN attendings and residents practicing at University Hospital of Mirebalais

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • OBGYN physician in Haiti

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureSurgical training

    This was a gyn laparoscopy training and simulation course

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What researchers measure

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.

    Time frame: 1 week

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Study locations

1 site
  • University Hospital at Mirebalais
    Mirebalais, Haiti
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04059328
Responsible party
Lara Harvey (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Aug 16, 2019
Start date
Sep 29, 2018
Primary completion
Oct 6, 2018
Completion
Oct 6, 2018
Last update
Aug 30, 2019

Study contacts

Lara Harvey, MD MPH
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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