Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02665000
Status:
UNKNOWN
Last Update Posted:
2016-03-22
First Post:
2016-01-22
Brief Title:
Evaluating the Effects of a Structured Training Program on the Learning Curve of Residents in Laparoscopic Surgery
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
11 Aim The investigators wish to validate a structured training program for junior residents to enhance their learning curves in performing laparoscopic appendectomy
12 Hypothesis To introduce a structured laparoscopic appendectomy training program and validate its efficacy with the validated GOALS scoring system
12 Hypothesis To introduce a structured laparoscopic appendectomy training program and validate its efficacy with the validated GOALS scoring system
Detailed Description:
2 Background and clinical significance 21 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 center1 A recent leading article by Kordowicz et al stated the challenges and the importance of having validated simulator training for individual centers2
22 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 outcomes34 Therefore investigators also hope that with a validated training program for the residents this can translate to improved patient outcomes and safety
23 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 31 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
32 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 procedure5
Residents who are in the post-graduate year 1PGY-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
33 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
34 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 005 a power of 080 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 residents 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 reinforcement7
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 35 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 eg 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
36 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
37 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
38 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
22 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 outcomes34 Therefore investigators also hope that with a validated training program for the residents this can translate to improved patient outcomes and safety
23 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 31 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
32 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 procedure5
Residents who are in the post-graduate year 1PGY-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
33 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
34 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 005 a power of 080 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 residents 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 reinforcement7
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 35 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 eg 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
36 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
37 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
38 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None