NCT03984292

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

May 26, 2019

Last Update Submit

July 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical Skills

    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.

    1 year

Study Arms (2)

Mass Learning

EXPERIMENTAL

Single teaching session of 3 hours shall be provided

Procedure: Teaching of laparoscopic skills on a box simulator

Distributed Learning

EXPERIMENTAL

Three teaching sessions of 1 hour each shall be provided.

Procedure: Teaching of laparoscopic skills on a box simulator

Interventions

The students shall be trained a laparoscopic simulator for a variable duration and the outcome shall be compared.

Distributed LearningMass Learning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • The students who refuse to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Study Officials

  • Muhammad Rizwan Khan

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor shall not be aware of the type of training which has been given to the students.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

May 26, 2019

First Posted

June 12, 2019

Study Start

February 7, 2019

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Individual data not to be shared

Locations