Impact of Behavioral Compliance Between Residents and Surgeons (CONF1)

October 27, 2024 updated by: Centro de Excelencia en Enfermedades de Cabeza y Cuello

Impact of Behavioral Compliance Between Residents and Surgeons Using a Simulation Environment of Trocar Placement in Laparoscopic Cholecystectomy

This study aims to evaluate the influence of perceived peer performance on the clinical skill of trocar placement during laparoscopic cholecystectomy among surgeons and surgical residents. It investigates whether exposure to incorrect trocar placements by peers affects the accuracy of subsequent placements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

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

  • Colombia
      • Bogota, Colombia
        • Asociacion Colombiana de Cirugia

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Over 18 years old
  • Spanish mother tongue
  • Experience in laparoscopic cholecystectomy
  • Consent to participate

Exclusion Criteria:

  • Physical disability preventing understanding or response
  • More than 3 years of suspension from surgical practice

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Participants use a laparoscopic model without any previous marks.
Behavioral: incorrect trocar placement marks.
Participants in the experimental group will perform trocar placements on laparoscopic models that have been pre-marked with incorrect insertion sites by previous participants. These marks simulate procedural steps or anatomical landmarks that are intentionally incorrect.
Experimental: Intervention
Participants use a laparoscopic model with incorrect trocar placement marks.
Behavioral: incorrect trocar placement marks.
Participants in the experimental group will perform trocar placements on laparoscopic models that have been pre-marked with incorrect insertion sites by previous participants. These marks simulate procedural steps or anatomical landmarks that are intentionally incorrect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of the trocar placements
Time Frame: 1 week

The participant must define in a graphic format the site where the trocars would be placed to perform a laparoscopic cholecystectomy.

The number of trocars correctly placed will be recorded. A rate of will be calculated: Trocars in the correct place/Total number of trocars.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Excelencia en Enfermedades de Cabeza y Cuello

Collaborators

Asociacion Colombiana de Cirugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 7, 2024

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

October 27, 2024

Study Registration Dates

First Submitted

August 4, 2024

First Submitted That Met QC Criteria

October 27, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 27, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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