Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03982927 |
| Other study ID # |
3011-Sur-ERC-14 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 13, 2016 |
| Est. completion date |
June 15, 2016 |
Study information
| Verified date |
June 2019 |
| Source |
Aga Khan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
There is no objective data on the outcome of a daylong workshop as commonly offered to the
surgical residents by various institutions. Hence we planned a study with the objectives to
determine if a one-day laparoscopic skills workshop enhanced the knowledge and skills of
surgical residents in minimal access surgery and did the workshop scores have any correlation
with the Direct Observation of Procedural Skills (DOPS) scores for the procedures performed
in the real life.
The results of our study shall indicate the impact of one-day laparoscopic skills workshop on
the knowledge and psychomotor skills of the surgical residents. The skills gained from the
workshop shall also be correlated with DOPS scores reflecting the transfer of skills to real
life performance.
Description:
I. Introduction and Background:
Teaching and learning of psychomotor skills is of paramount importance for surgical residency
programs. The 'traditional' model of teaching surgical skills on 'real' patients using graded
responsibility is being seriously questioned. More and more focus has recently shifted on the
use of models and simulators, with an objective of better preparation of residents for the
operating room experience. At Aga Khan University, the focus of surgical training is still on
the traditional model, but some innovations have been introduced to enhance the training
outcomes and safety of the patients. The innovations include use of short workshops on bench
models to train the residents in basic surgical skills before they can operate on the real
patients.
The educational impact of such short workshops has been difficult to document, since a
long-term follow up is usually not possible. But some recent data suggests that minimal
access skills workshops can improve both the knowledge base and motor skills of the trainees.
There is also some data to suggest that the skills obtained during a workshop not only have a
long lasting effect on the performance of the residents, but may also result in change in
practice of the participants. There is no study available where the educational effect of
surgical workshop has been correlated with the real time work place based performance of the
surgical residents including DOPS (direct observation of procedural skills). DOPS is a form
of work place based assessment of residents' knowledge and skills, and can be used as a
surrogate marker for the actual performance of the residents in the real world. Improvement
of DOPS scores after the workshop might demonstrate the educational influence of the workshop
on the residents' knowledge and skills.
II. Rationale and Objective of the Study:
The section of General Surgery at Aga Khan University offers surgical skills workshops to
trainees every year to enhance their knowledge and psychomotor skills for the last many
years. There is a general perception amongst the trainees and the faculty that these
workshops have been quite valuable in refining the skills of the surgical trainees. However,
there is no objective data to support this perception and hence there is a need to document
the outcome of this important academic activity.
The basic questions that need to be answered are; if there is an effect of laparoscopic
skills workshop on enhancing the knowledge and skills of surgical residents and how do the
workshop scores correlate with the DOPS (Direct Observation of Procedural Skills) scores. The
results of this study may be used for improving the teaching methods for surgical residents
as well as the enthusiasm of the faculty involved in such labor intensive activities.
The objective of our study is to determine the difference in the mean scores of knowledge and
skills assessment of surgical residents attending the minimal access skills workshop before
and after the workshop; and at an interval of 2 months. The second objective is to compare
the workshop scores with the DOPS (Direct Observation of Procedural Skills) scores conducted
before and after the workshop during the same study period.
III. Methods:
Study Design: This will be a quasi-experimental, single arm, repeat measure study design. The
pre-workshop knowledge and skills scores of residents will be compared with immediate
post-workshop scores and scores of repeat assessment at 2 months after the workshop. The
scores of DOPS on laparoscopic surgery before and after the workshop will also be compared
for any change.
Participants: The trainees enrolled in the residency programs of General Surgery and
Obstetrics / Gynecology of Aga Khan University have the mandate of acquiring skills of
minimal access surgery as a part of their surgical armamentarium. These residents will be
invited to participate in the proposed study and the workshop.
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 30+. The residents will be divided into two groups based on their expected
exposure to minimal access surgery Group I: year 1 & 2 residents Group II: year 3, 4 & 5
residents
Setting: The workshop will be a one-day event and conducted at the Anatomy Dissection Hall of
the Aga Khan University.
Pre-workshop Assessment:
There will be an MCQs based pre-test to assess the basic knowledge of the residents. The
questions will be related to the knowledge of abdominal anatomy, electro-cautery, harmonic
scalpel, laparoscopic instruments, port insertion techniques, physiological effects of
laparoscopy, complications and management of laparoscopic surgery.
This will be followed by assessment of baseline psychomotor skills of the residents on
laboratory-based models. The skills assessed will focus on port insertion, hand-eye
coordination and depth perception.
Intervention: The training workshop will consist of didactic lectures, videos and live
demonstrations on the basic knowledge and skills related to the minimal access surgery. The
components of workshop will include:
1. A lecture focused on introduction to laparoscopic surgery including equipment /
instruments, energy sources, operating room setup and team work.
2. Video demonstration of various techniques of creating pneumoperitoneum followed by
hands-on practice on bench model.
3. A tutorial on physiological effects, complications and outcome of laparoscopic surgery.
4. Live demonstration of following techniques of minimal access surgery with focus on
hand-eye coordination and depth perception, followed by hands-on practice.
1. Transfer of bean balls across dishes
2. Passing thread through hooks
3. Passing rope in graspers / running rope
4. Cutting a circle on gauze with endo-scissors The various components of the workshop
will be spaced by intervals of refreshment and adequate time for hands-on practice
to avoid fatigue. (Please see the attached workshop program for time
specifications)
Post-workshop Assessment: The workshop will be followed by an immediate post-course
assessment consisting of an MCQ test as well as assessment of psychomotor skills on a
previously designed preforma.
Interval Assessment: All the participants of the workshop will be asked to keep a log of
their involvement in minimal access procedures during the next two months. The purpose of log
keeping is to assess their involvement in such procedures which may have an independent
effect on their skills as compared to the influence of the workshop alone. At the end of this
period, these residents will be invited to an interval assessment of their surgical skills on
a previously designed performa to document the durability of surgical skills.
Assessment of Performance: The technical skills of the residents will be video-recorded at
all three stages of assessment. The skills will be scored by two independent surgeons using
the GOALS scoring system.18 The scores will be compared for inter-rater reliability and any
difference will be sorted out by mutual discussion. Surgery residents routinely perform the
DOPS and scores will be taken for DOPS performed on minimal access surgery before and after
the workshop.
Statistical Analysis: Demographic data will be described in frequencies / percentage, while
the pre and post MCQ / skills mean scores (3 readings) will compared by using repeat measures
of ANOVA. Pre and post DOPS scores (2 readings) will be compared by using paired t test. The
scores of MCQs, skills and DOPS will be compared by using correlation coefficient (Pearson
r).
The effect of year of residency on scores will be analyzed by using one way ANOVA. Construct
validity of the intervention will be calculated by comparing the scores of various years /
level of experience. Inter-rater reliability of assessors will be assessed by comparing the
scores of two assessors (Bald Altman test).
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.
IV. Results:
The detailed results will be given after completion of the study. It is expected that
post-workshop knowledge and assessment scores of surgical residents will be better as
compared to pre-workshop scores. The performance of residents in DOPS will also improve after
the workshop. It is also expected that the scores of the senior residents will be better than
the junior residents.
V. Conclusions:
The results of the study will objectively establish the effect of surgical skills workshop on
enhancing the knowledge and skills of the surgical residents. Te study will also demonstrate
the correlation between the workshop and DOPS scores.
