Mixed Method Study Protocol_Cognitive Non-technical Skills Learning Module for a Safe Laparoscopic Cholecystectomy

October 24, 2022 updated by: Adianto Nugroho, RSUP Fatmawati

The Role Cognitive Non-technical Skills Learning Module in Promoting A Safe Laparoscopic Cholecystectomy: Critical Analysis on Situation Awareness and Intraoperative Decision Making in the Prevention of Complications

A mixed-methods sequential explanatory design study. The first quantitative phase will be an online survey to surgeons that includes questions related to their experience learning and performing laparoscopic cholecystectomy. The second qualitative phase will use depth interview to elaborate surgeon's experience regarding a safe laparoscopic cholecystectomy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. Cognitive non-technical skills namely situation awareness and decision-making skills are essential in doing a safe laparoscopic cholecystectomy, as in any kind of surgery. Studies regarding cognitive non-technical skills and how to teach them are still lacking, especially in the field of surgery.

With this study, the investigators aim to formulate a comprehensive learning module for a safe laparoscopic cholecystectomy accomodating cognitive non-technical skills based on the surgeon's experience while learning and doing laparoscopic cholecystectomy.

Study Type

Observational

Enrollment (Anticipated)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgeons and Surgical residents

Description

Inclusion Criteria:

  • Surgeons and / or surgical residents
  • Complete all the required documents

Exclusion Criteria:

  • Refuse to participate in one or more parts of the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative: Community Survey
Time Frame: February - March 2022
Survey data
February - March 2022
Qualitative: In Depth Interview
Time Frame: March - April 2022
Semi-structured interview data obtained from In Depth Interview
March - April 2022
Qualitative: Delphi Study
Time Frame: May 2022
Learning Module
May 2022

Collaborators and Investigators

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

Sponsor

RSUP Fatmawati

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)

February 5, 2022

Primary Completion (ANTICIPATED)

January 31, 2023

Study Completion (ANTICIPATED)

January 31, 2023

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (ACTUAL)

March 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-01-0029

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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