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Development of Laparoscopic Skills in Medical Students - What Makes the Difference?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03984292
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Muhammad Rizwan Khan, Aga Khan University

Brief Summary:

Learning is a complex process and influenced by a number of factors including the innate ability of the trainee, previous experiences (e.g. video game skills, music instrument skills), learning style and the overall learning environment. Understanding of the learning process and factors influencing the learning shall help develop and plan an effective curriculum for the trainees.

The investigators plan to use medical students as a part of the study since they have little or no prior knowledge or experience of laparoscopic skills. If any factors are identified, the investigators can help guide the participants for future training as well as develop a comprehensive curriculum for the current surgical trainees.

The primary objective of the study is to determine if acquisition and retention of laparoscopic skills in medical students is superior with multiple training sessions as compared to a single training session of the similar duration.


Condition or disease Intervention/treatment Phase
Clinical Skills Procedure: Teaching of laparoscopic skills on a box simulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The students will be randomly distributed into two groups by using pre-designed envelopes:

Group I: Single teaching session of 3 hours at single encounter Group II: 3 teaching sessions of 1 hour each over a period of 3 weeks The study will be open to all the year 2, 3 and 4 medical students of Aga Khan University Medical College and recruitment shall be done on first come-first serve basis.

Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor shall not be aware of the type of training which has been given to the students.
Primary Purpose: Basic Science
Official Title: Development of Laparoscopic Skills in Medical Students - What Makes the Difference?
Actual Study Start Date : February 7, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Arm Intervention/treatment
Experimental: Mass Learning
Single teaching session of 3 hours shall be provided
Procedure: Teaching of laparoscopic skills on a box simulator
The students shall be trained a laparoscopic simulator for a variable duration and the outcome shall be compared.

Experimental: Distributed Learning
Three teaching sessions of 1 hour each shall be provided.
Procedure: Teaching of laparoscopic skills on a box simulator
The students shall be trained a laparoscopic simulator for a variable duration and the outcome shall be compared.




Primary Outcome Measures :
  1. Clinical Skills [ Time Frame: 1 year ]
    Clinical skills of students shall be assessed by using the GOALS (global operative assessment of laparoscopic skills) scale for assessment of clinical skills in laparoscopy. This is a validated tool and has 5 parameters assessed on a Likert scale of 1 to 5. Higher the score, better the value.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical students of years 2, 3 and 4 with interest in laparoscopic surgery skills who volunteer to participate in the study

Exclusion Criteria:

  • The students who refuse to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984292


Locations
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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Muhammad Rizwan Khan Aga Khan University
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Responsible Party: Muhammad Rizwan Khan, Associate Professor of Surgery, Aga Khan University
ClinicalTrials.gov Identifier: NCT03984292    
Other Study ID Numbers: 172008SUR
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data not to be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No