Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03984292 |
| Other study ID # |
172008SUR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 7, 2019 |
| Est. completion date |
February 28, 2020 |
Study information
| Verified date |
July 2020 |
| Source |
Aga Khan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study Design:
This will be a parallel randomised controlled study design with a 1:1 ratio in each arm
studying the influence of duration and number of training encounters on the acquisition of
laparoscopic surgery skills.
Setting: The training shall be conducted at the Centre for Innovation in Medical Education
(CIME) of the Aga Khan University, Karachi, Pakistan. The data shall be collected and
analysed at the department of surgery of Aga Khan University, Karachi, Pakistan.
Study Participants: Year 2, 3 and 4 medical students of Aga Khan University Medical College,
Karachi, will be invited to voluntarily participate in the study.
Sample Size & Groups: A non-probability, all-inclusive sampling technique will be used. A
voluntary participation will be required and the expected number of participants has been
estimated to be 50 in each group. 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. The sample size of 50 has been calculated based on the
convenience using the data from previous studies. The usual class at AKU consists of 100
students and it is expected that at least 33% would consent to participate in the study.
There are no specific exclusion criteria for this group of medical students.
Intervention: The intervention will be based on training sessions of 15-minute tutorial on
basic principles of instrument handling, depth perception and hand eye coordination followed
by live demonstration of specific tasks. This will be followed by hands-on practice by the
participants of the following tasks:
1. Transfer of pegs / bean balls across dishes by non-dominant hand
2. Passing thread through hooks using dominant hand
3. Precision cutting - cutting a circle on gauze / paper with endo-scissors The
participants in each arm will be further sub-divided in a group of 10 and each sub-group
will be facilitated by a designated general surgeon who is expert in laparoscopic
skills.
For group I, there will be 'one' training session lasting for 3 hours. For group II, the
training shall consist of 'three' sessions of one hour each distributed over a period of 3
weeks. Hence the total duration of training will be the same in both groups, but the period
of learning shall be different.
Outcome Assessment:
1. Baseline Assessment: At the initial encounter, an informed consent shall be taken from
the medical students and they will be asked to complete a questionnaire describing their
demographics, dominant hand, interest in future specialty and hobbies including playing
video games and musical instruments. This will be followed by assessment of baseline
psychomotor skills of the participants on laboratory-based models (described below). The
skills assessed will focus on use of dominant hand, depth perception, and hand-eye
coordination.
2. Pre- and Post-intervention Assessment: The participants shall be asked to complete the
specific tasks described above before and after the intervention. The performance shall
be monitored by the designated supervising faculty with expertise in laparoscopic skills
and graded in terms of efficiency and quality of performance. The scale used to grade
the students' skills will be the previously validated scale for assessment of
laparoscopic skills known as GOALS (Global assessment of laparoscopic skills)21. Each
participant shall be given 300 seconds to complete each task with negative marking for
any deviation. Pre-intervention assessment shall be performed immediately before the
training for both the groups while post-intervention assessment shall be performed at
the completion of total duration of training for each group i.e. immediate for group I
and at 3 weeks for group II.
3. Interval Assessment: All the participants will be scheduled for interval assessment of
their skills at 3 months, 6 months and 1-year after the intervention. It is expected
that the students shall not undergo any formal training in laparoscopic skills since
this is not a part of their curriculum, but they can continue with their hobbies. The
rationale behind this on-going assessment is to monitor longitudinal retention of
knowledge after short learning encounters.
Assessment of Performance: Actual content and duration of training of the two groups shall be
similar except that one group shall have a single session of mass training while the second
group shall have 3 sessions of distributed practice. The technical skills of the students
shall be assessed by the surgeons experienced in laparoscopic surgery as well as assessment
of performance of medical students. The surgeon performing the assessment before and after
the intervention shall be blinded to the type of training offered to the students. The
assessment will be objective in terms of time duration taken to complete the task with
negative marking for any deviation. If student is unable to complete the task during the
given time frame, additional time required to complete the task shall be calculated based on
the actual part of the task completed.
Randomization: The students in each arm will be randomized by using the pre-designed
envelopes. The selection of students, development of blinded envelopes and randomization will
be done by the primary investigator. The facilitating faculty shall be aware of the
randomization for each group, but the assessing faculty shall be kept blinded to this
randomization.
Statistical Analysis: Demographic data and distribution of hobbies will be described in
frequencies and percentage. The scores at various readings will be described as mean, median,
minimum and maximum values with standard deviations. The pre-intervention, post-intervention
and interval assessment mean scores will be compared by using repeat measures of ANOVA. The
effect of gender and hobbies on the scores will be analyzed by using one way ANOVA. The level
of significance will at 0.05.
Ethical Clearance: An ethical approval for the conduct of the study will be obtained from the
institutional ethics committee. An informed consent will be obtained from the participants
for inclusion in the study.
