An interventional study of Proficiency-based virtual reality simulation training and Training under the current surgical training programme in Colorectal Disease, sponsored by Royal College of Surgeons, Ireland. Status unknown at 10 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-07.
Sponsored by Royal College of Surgeons, Ireland · Not applicable and Interventional
Laparoscopic Colectomy is an advanced minimally invasive procedure that requires advanced laparoscopic skills.
Minimally invasive surgery offers many advantages to the patients but exposes the surgeon to new challenges, many of which are human factor in nature. This in turn prolongs the learning curve and has delayed the widespread adoption of minimally invasive surgical techniques in the management of patients with colorectal disease.
Virtual reality simulation offers an effective way of training whereby surgical trainees can train repeatedly and achieve proficiency in a shorter time and a safe environment.
Introduction:
Minimally Invasive Surgery (MIS) has conferred considerable advantages on patient's post operative outcome and recovery when compared with open surgery.
Major clinical trials including; Clinical Outcomes of Surgical Therapy Study Group (COSTSG), Colon Cancer Laparoscopic or Open Resection (COLOR), and Conventional vs. Laparoscopic-Assisted Surgery in Colorectal Cancer (CLASICC) have uniformly and consistently shown a significant reduction in the post operative pain, the use of narcotics and oral analgesics, and length of hospital stay, as well as a faster resumption of diet, return of bowel function when using a MIS approach.
Despite all these advantages to the patients, MIS imposed a significant difficulty on the surgeons. These difficulties were primarily human factor in nature.
The use of Virtual Reality (VR) simulation has been proven to help in the acquisition of MIS skills. The use of proficiency-based, virtual reality simulation should help training of MIS providers in a safe environment where complex tasks can be repeated as many times as needed to achieve a pre-set proficiency level. A well designed proficiency-based simulation curriculum should help the widespread use of the MIS approach.
Aims
Primary:
We aim to prove that subjects randomised to train under a proficiency-based progression simulation curriculum (SC) will learn to perform laparoscopic assisted colectomy faster, complete more surgical steps and commit fewer operative errors compared to subjects randomised to the current surgical training curriculum (CC)
Secondary:
We aim to set the institutional and national proficiency level for Laparoscopic Assisted Colectomy (LAC) using the ProMIS-LAC simulator from Haptica, Ireland.
Methods Randomised, controlled, single blinded, multicentre study. Primary Variable 8 centres, 8 co-investigators (expert consultant laparoscopic colorectal surgeons > 300 MIS procedures) and 16 surgical trainees will be recruited for the study. Subjects (surgical trainees) will be randomised into;
Subjects randomised to the CC group will continue to have the conventional training programme offered at their respective hospitals. Subjects randomised to the SC group will complete a standardised laparoscopic skills training course followed by a training curriculum including the performance of simulated LAC procedures in nine predetermined steps on the simulator. Subjects must reach a predetermined proficiency level to complete the simulation training course before re-joining their training programme offered at their respective hospitals. .
Upon completion of the training courses, both groups' subject populations will perform a total of five LAC procedures on consecutive patients in the presence of a surgeon proctor.
Patients indicated for LAC procedure will be screened, consented, and enrolled as patients into this study. Each procedure will be recorded and forwarded to the chief investigator for analysis. The number of completed surgical steps and the incidence of intraoperative errors between the two SC and CC groups will be evaluated via blinded video review.
Secondary Variable
All participating co-investigators will participate in defining the proficiency level for LAC on the ProMIS-LAC simulator.
The average values of the recorded metrics which are obtained from the expert performance will be used to set the proficiency level.
Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for subjects
Exclusion criteria for subjects
Inclusion criteria for patients
Exclusion criteria for patients
Subjects (surgical trainees) randomised to train under a proficiency-based progression virtual reality simulation curriculum
Other: Proficiency-based virtual reality simulation training
Subjects (surgical trainees) randomised to the current surgical training curriculum
Other: Training under the current surgical training programme
Subjects (surgical trainees) will be trained under a proficiency-based virtual reality simulation training programme before performing their first live case
Also known as: Simulation Curriculum, SC
Subjects (surgical trainees) will continue to train under the current training methodology offered at their institution before they perform their first live case.
Also known as: Current Curriculum, CC
Subjects randomised to train under a proficiency-based simulation curriculum (SC) will perform laparoscopic assisted colectomy faster, complete more surgical steps and commit fewer operative errors compared to subjects randomised to the control group
Time frame: 6-12 months
We aim to set the institutional and national proficiency level for Laparoscopic Assisted Colectomy (LAC) using the ProMIS-LAC simulator from Haptica, Ireland.
Time frame: 30 days
This study is status unknown, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Royal College of Surgeons, Ireland