Laparoscopic Appendectomy Clinical Trial
Official title:
A Randomised Controlled Trial Evaluating the Effects of a Structured Training Program on the Learning Curve of Residents in the Field of Laparoscopic Surgery (STAR Trial)
1.1 Aim The investigators wish to validate a structured training program for junior
residents to enhance their learning curves in performing laparoscopic appendectomy.
1.2 Hypothesis To introduce a structured laparoscopic appendectomy training program and
validate its efficacy with the validated GOALS scoring system.
2. Background and clinical significance 2.1 Background The use of simulated training has
been popularized for surgical techniques as it provides spatial and task oriented training
which is vital for surgery. As more and more junior residents are performing laparoscopic
appendectomy under supervision by registrars, the concern of patient safety of such early
exposure without a prior structured training program is questioned. Furthermore, as these
procedures are performed after office hours in our center, performance of this procedure by
junior doctors may result in higher conversion rates according to a retrospective study done
in our center.1 A recent leading article by Kordowicz et al stated the challenges and the
importance of having validated simulator training for individual centers.2
2.2 Potential clinical significance The investigators propose that a validated training
program will allow a safer training environment for junior residents. This will help to
provide a standard laparoscopic training program that can be used for the training of future
batches of surgical trainees coupled with improved learning curves and surgical techniques.
Studies done both locally and overseas have also shown that the presence of junior doctors
in such operations can potentially increase operating time and poor surgical outcomes.3,4
Therefore, investigators also hope that with a validated training program for the residents,
this can translate to improved patient outcomes and safety.
2.3 Potential benefits to the participants Direct benefit to the subjects include provision
of a structured training program for participants randomized to Group A. Subjects in both
groups will also receive critical assessment and feedback on their laparoscopic skills, thus
contributing to the development of their surgical skills.
3. Methods Approach 3.1 Methodology A randomized controlled trial for junior surgical
residents with less than 10 laparoscopic appendectomies' experience as first surgeon will be
recruited. They will be randomized to either Group A or Group B (control).
3.2 Participants selection Junior surgical residents with less than 10 laparoscopic
appendectomies' experience as first surgeon will be recruited. Up to 20 cases of
laparoscopic appendectomies was shown to be the number required for a junior resident to
become competent in the procedure.5
Residents who are in the post-graduate year 1(PGY-1) will be excluded from the study. This
is as PGY-1 residents will be required to perform House Officer (HO) duties and as such do
not participate in or perform any laparoscopic appendectomy procedures. Therefore, only
surgical residents from PGY-2 to PGY-5 will be recruited.
3.3 Training Program Participants in Group A will undergo 5 days training program in
laparoscopic appendectomy using the Box Trainer and Wet Trainer, whereas Group B will not
receive any additional training during this week. Each training session will take up to 2
hours. Both groups will then be exposed to the standard training in current practice over 5
supervised cases of laparoscopic appendectomy.
After the above training, they will all be required to perform another 5 cases of
laparoscopic appendectomy as performing surgeon under supervision by a trained surgeon. The
operation will be recorded and then graded based on a validated GOALS scoring system 6
(Appendix A). The Primary Outcome will be the difference of the GOALS results between the 2
groups. Secondary outcomes will include OSAT score (Appendix B), patient outcome, residents'
feedback score as well as conversion rates to open surgery.
3.4 Conducting the study The study subjects will be randomly assigned by a
computer-generated randomization process to receive either the structured training program
prior to standard current training practice (Group A) or only the standard current training
practice (Group B, control).
A power calculation was performed to assess the number of participants required in the
control and intervention groups. To detect a difference in GOALS score of 4, assuming an
alpha of 0.05, a power of 0.80, the minimum number of subjects needed is 16.
All recruited residents will go through an aptitude test on the simulator to ensure
comparability of the 2 groups prior to intervention.
Residents in Group A will receive up to 2 hours of supervised training by a trained surgeon
per day for 5 days. The 2 hours will include a 30 minutes discussion on the training cases
for the day, a 1 hour hands on practice with the Box Trainer as well as Wet Training
followed by a 30 minutes feedback session.
Both groups will then be exposed to 5 cases of laparoscopic appendectomy with a trained
surgeon as per current training practice.
The participants would then be graded for the next 5 cases of laparoscopic appendectomy that
they perform. The assessment will include GOALS scoring by:
1. The supervising registrar
2. 2 consultant surgeons who will grade the resident's performance individually based on
the video recording of the surgery
The study will be single-blinded as the assessors will not know which group each resident
belong to. Blinding of residents would not be possible in this study. However, this would
not affect the results of the primary outcome.
The laparoscopic appendectomies will be performed within a time period of 6 months as
studies have shown that the effect of laparoscopic training do not persist beyond 6 months
without any reinforcement.7
Feedback scores will be collated for all residents on completion of the study. The feedback
scores will detail the level of confidence of the resident during the performance of the
assessed cases and will be compared between the 2 groups.
A short summary of the process is as follows:
1. Consent of all subjects will be obtained
2. Pre-intervention aptitude assessment will be done for both Group A and B
3. 5 days of structured training program for subjects in Group A
4. Both groups will have a repeat aptitude test.
5. Both groups perform 5 training cases supervised by a trained surgeon, as of current
training standards.
6. Assessment of subsequent 5 cases of laparoscopic appendectomies of subjects in both
groups will be done by the senior surgeon assisting in each case as well as 2
independent consultant surgeons. This will be scored with the GOALS assessment.
7. Feedback scores on the level of confidence and competence in performing the 5 assessed
cases will be collated for all subjects 3.5 Advantages of our study methodology Thus
far, there have not been any locally validated training programs in literature. The
studies on laparoscopic studies which have been conducted and validated overseas tend
to focus on whether the use of a particular training tool (e.g. the use of laparoscopic
stimulator, didactic lectures etc.) will be useful in improving the learning curves of
the trainees.
Therefore, our research methodology is unique as it attempts to integrate the different
training modalities that have been proven to improve the training curve into one seamless
training program for the trainees. This seamless training will include didactic lectures as
well as training on multiple different modalities, all of which has been shown in
international journals to improve the learning curve of the trainees.
3.6 Potential limitations of the study Potential limitations will include
1. The difficulty level of each case of appendectomy will be different. This effect will
be mitigated with randomization of the subjects to the 2 groups. In addition, the GOALS
assessment takes into consideration the level of difficulty of the particular case and
this will be reflected in the final score.
2. The amount of intervention from the registrar who is assisting in the surgery with the
subject will differ. The GOALS assessment takes this into account and will allow the
registrar to quantify the amount of assistance that was rendered intra-operatively.
This will thus be reflected in the final score.
3.7 Potential harm/ hazard to participants and patients There are no potential risks to the
patients in this study as the control arm residents will be receiving the same supervision
as in our current day practice. All patients under this study will also go through the
standard of care of laparoscopic appendectomy and no additional costs will be borne by the
patients.
Similarly, for the participants in Group B (those who do not undergo the training program),
the participants will not be in any form of disadvantage as they will still be undergoing
the current training protocol.
3.8 Analyzing the data All the information that was recorded will be consolidated into a
central form for each of the participants. The information obtained will be kept
confidential and be kept in the office of the principal investigator (PI). Access to the
information will only be given to the PI, co-PI and the collaborators.
The results of the trial will only be analyzed after completion of data collection. There
will be no preliminary analysis.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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