Evaluating the Effects of a Structured Training Program on the Learning Curve of Residents in Laparoscopic Surgery
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 other identifier
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
2 active sites
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
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedMarch 22, 2016
March 1, 2016
3.8 years
January 22, 2016
March 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The difference of the GOALS results between the 2 groups
6 months
Study Arms (2)
Study arm: Structured training programme
EXPERIMENTALThe participants in study arm will undergo 5 days training program in laparoscopic appendectomy using the Box and Wet Trainer as intervention. Each training session will take up to 2 hours. The participant will then be exposed to the standard training in current practice over 5 supervised cases of laparoscopic appendectomy. After the above training, they will 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 graded based on a validated GOALS scoring system 6. The Primary Outcome will be the difference of the GOALS results between the 2 groups. Secondary outcomes will include OSAT score, patient outcome, residents' feedback score as well as conversion rates to open surgery.
Control arm: non-training
NO INTERVENTIONParticipant in study arm will not receive any additional training during the training week. The participant will then be exposed to the standard training in current practice over 5 supervised cases of laparoscopic appendectomy. They will 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
Interventions
Participants will undergo 5-days training sessions
Eligibility Criteria
You may qualify if:
- Junior surgical residents with less than 10 laparoscopic appendectomies' experience as first surgeon will be recruited
You may not qualify if:
- Residents who are in the post-graduate year 1(PGY-1) will be excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National University Hospital
Singapore, Singapore, 119074, Singapore
National University Hospital
Singapore, Singapore, 119228, Singapore
Related Publications (7)
So JB, Chiong EC, Chiong E, Cheah WK, Lomanto D, Goh P, Kum CK. Laparoscopic appendectomy for perforated appendicitis. World J Surg. 2002 Dec;26(12):1485-8. doi: 10.1007/s00268-002-6457-7. Epub 2002 Sep 26.
PMID: 12297916BACKGROUNDKordowicz AG, Gough MJ. The challenges of implementing a simulation-based surgical training curriculum. Br J Surg. 2014 Apr;101(5):441-3. doi: 10.1002/bjs.9370. Epub 2014 Feb 26. No abstract available.
PMID: 24615294BACKGROUNDDavis SS Jr, Husain FA, Lin E, Nandipati KC, Perez S, Sweeney JF. Resident participation in index laparoscopic general surgical cases: impact of the learning environment on surgical outcomes. J Am Coll Surg. 2013 Jan;216(1):96-104. doi: 10.1016/j.jamcollsurg.2012.08.014. Epub 2012 Sep 19.
PMID: 22999330BACKGROUNDPapandria D, Rhee D, Ortega G, Zhang Y, Gorgy A, Makary MA, Abdullah F. Assessing trainee impact on operative time for common general surgical procedures in ACS-NSQIP. J Surg Educ. 2012 Mar-Apr;69(2):149-55. doi: 10.1016/j.jsurg.2011.08.003. Epub 2011 Oct 2.
PMID: 22365858BACKGROUNDGumbs AA, Hogle NJ, Fowler DL. Evaluation of resident laparoscopic performance using global operative assessment of laparoscopic skills. J Am Coll Surg. 2007 Feb;204(2):308-13. doi: 10.1016/j.jamcollsurg.2006.11.010. Epub 2006 Dec 27.
PMID: 17254935BACKGROUNDSchell SR, Flynn TC. Web-based minimally invasive surgery training: competency assessment in PGY 1-2 surgical residents. Curr Surg. 2004 Jan-Feb;61(1):120-4. doi: 10.1016/j.cursur.2003.08.011.
PMID: 14972187BACKGROUNDPang NQ, Chua HW, Kim G, Tan MY, Bin Abdul-Aziz MND, Xu RW, Chen E, Teo SC, Khoo NX, Lomanto D, Tai BC, So JB, Chong CS. Structured Training for Laparoscopic Appendectomy for Residents (STAR Trial)-A Randomized Pilot Study. J Surg Res. 2021 Dec;268:363-370. doi: 10.1016/j.jss.2021.06.073. Epub 2021 Aug 14.
PMID: 34399358DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Choon Seng Chong, MBBS
National University Hospital, Singapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2016
First Posted
January 27, 2016
Study Start
August 1, 2014
Primary Completion
June 1, 2018
Last Updated
March 22, 2016
Record last verified: 2016-03