Status:
UNKNOWN
Creating a Proficiency-Based Virtual Reality Simulation Training Programme for Laparoscopic Assisted Colectomy
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
Health Service Executive
Conditions:
Colorectal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 surgeo...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00752817
Start Date
September 1 2008
End Date
September 1 2009
Last Update
October 7 2008
Active Locations (10)
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1
Mercy University Hospital
Cork, Ireland
2
AMNCH
Dublin, Ireland, 24
3
St. Vincent's University Hospital
Dublin, Ireland, 4
4
Beaumont Hospital
Dublin, Ireland, 9