Creating and Implementing a Proficiency-Based Progression Virtual Reality Training Programme for Higher Surgical Trainees for Laparoscopic Assisted Sigmoid Colectomy.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 16
- Locations
- 14
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •for subjects
- •Classified as year 3-5 post graduation registrars, specialist registrars or residents in surgery.
- •Completed their Basic Surgical Training programme.
- •Completed at least 12 months period on a Higher Surgical Training programme.
- •In an accredited surgical post at time of participation
- •In a colorectal surgery rotation at time of participation
- •Signed their own consent form
Exclusion Criteria
- •for subjects
- •Performed, as primary surgeon, > 10 advanced laparoscopic procedures (laparoscopic cholecystectomy, inguinal hernia, appendectomy, Nissen fundoplication, or ventral incisional hernia repair are not considered advanced laparoscopic procedures )
- •Performed, as primary surgeon, laparoscopic assisted colectomy procedures
- •Performed, as primary surgeon, any hand-assisted laparoscopic colectomy procedures
- •Did not sign their own consent form
- •Inclusion criteria for patients
- •Indicated for a laparoscopic assisted sigmoid colectomy or high anterior resection
- •At least 18 years old upon date of signing the informed consent document (ICD)
- •Sign their own ICD
- •Exclusion criteria for patients
- •History or current diagnosis of synchronous colon cancer
- •Indicated for urgent surgery
- •Indicated for diverting stoma
- •American Society of Anaesthesiologists (ASA) Classification of Physical Status IV-V
- •Tumour classified as T4
- •An obstructed colon
- •Planned early conversion based on findings at operative visualisation.
- •Pregnancy
- •< 18 years of age
- •Mental disability
- •Did not sign their own ICD
Outcomes
Primary Outcomes
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
Secondary Outcomes
- We aim to set the institutional and national proficiency level for Laparoscopic Assisted Colectomy (LAC) using the ProMIS-LAC simulator from Haptica, Ireland.(30 days)