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Creating a Proficiency-Based Virtual Reality Simulation Training Programme for Laparoscopic Assisted Colectomy (LAC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Royal College of Surgeons, Ireland.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Health Service Executive
Information provided by:
Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier:
NCT00752817
First received: September 11, 2008
Last updated: October 6, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention
Colorectal Disease
Other: Proficiency-based virtual reality simulation training
Other: Training under the current surgical training programme

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Creating and Implementing a Proficiency-Based Progression Virtual Reality Training Programme for Higher Surgical Trainees for Laparoscopic Assisted Sigmoid Colectomy.

Further study details as provided by Royal College of Surgeons, Ireland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC
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) will be trained under a proficiency-based virtual reality simulation training programme before performing their first live case
Other Names:
  • Simulation Curriculum
  • SC
Active Comparator: CC
Subjects (surgical trainees) randomised to the current surgical training curriculum
Other: Training under the current surgical training programme
Subjects (surgical trainees) will continue to train under the current training methodology offered at their institution before they perform their first live case.
Other Names:
  • Current Curriculum
  • CC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752817

Locations
Ireland
Mercy University Hospital
Cork, Ireland
AMNCH
Dublin, Ireland, 24
St. Vincent's University Hospital
Dublin, Ireland, 4
Beaumont Hospital
Dublin, Ireland, 9
AMNCH
Dublin, Ireland, Co. Dublin
Tullamore general hospital
Tullamore, Ireland, Co Offaly
United Kingdom
Antrim Area Hospital
Antrim, United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom
Leicester Royal Infirmary Hospital
Leicester, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Health Service Executive
Investigators
Principal Investigator: Paul Neary, MD, FRCSI Royal College of Surgeons in Ireland
  More Information

Publications:

Responsible Party: Professor Anthony Gallagher, PhD, Royal College of Surgeons in Ireland (RCSI)
ClinicalTrials.gov Identifier: NCT00752817     History of Changes
Other Study ID Numbers: RCSI 3 
Study First Received: September 11, 2008
Last Updated: October 6, 2008
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Royal College of Surgeons, Ireland:
Virtual Reality
Simulator
Proficiency
Laparoscopic
Colectomy
Education
Surgical Training

ClinicalTrials.gov processed this record on January 14, 2017