Creating a Proficiency-Based Virtual Reality Simulation Training Programme for Laparoscopic Assisted Colectomy (LAC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Royal College of Surgeons, Ireland.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Royal College of Surgeons, Ireland
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
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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:
|
|
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752817
Contacts
| Contact: Musallam A Al-Akash, MBBS, MRCSI | +35314022703 | malakash@rcsi.ie |
Locations
| Ireland | |
| Mercy University Hospital | Recruiting |
| Cork, Ireland | |
| Contact: Michael O'Riordain, MD, FRCS +353 21 4935336 | |
| Sub-Investigator: Michael O'Riordain, MD, FRCSI | |
| AMNCH | Recruiting |
| Dublin, Ireland, Co. Dublin | |
| Contact: Paul Neary, MD, FRCSI +35314142000 | |
| Principal Investigator: Paul Neary, MD, FRCSI | |
| AMNCH | Recruiting |
| Dublin, Ireland, 24 | |
| Contact: Dairmuid O'Riordain, MD, FRCSI +353 1 414 2213 | |
| Sub-Investigator: Dairmuid O'Riordain, MD, FRCSI | |
| Beaumont Hospital | Recruiting |
| Dublin, Ireland, 9 | |
| Contact: Deborah McNamara, MD, FRCSI +353 1 8093000 | |
| Sub-Investigator: Deborah McNamara, MD, FRCSI | |
| St. Vincent's University Hospital | Recruiting |
| Dublin, Ireland, 4 | |
| Contact: Desmond Winter, MD, FRCSI +353 1 2214000 | |
| Sub-Investigator: Desmond Winter, MD, FRCSI | |
| Tullamore general hospital | Recruiting |
| Tullamore, Ireland, Co Offaly | |
| Contact: Dermot Hehir, FRCSI +35357 93 22206 | |
| Sub-Investigator: Dermot Hehir, FRCSI | |
| United Kingdom | |
| Antrim Area Hospital | Recruiting |
| Antrim, United Kingdom | |
| Contact: Colman Byrnes, MD, FRCS +44 028 9442 4000 | |
| Sub-Investigator: Colman Byrnes, Md, FRCS | |
| Gartnavel General Hospital | Recruiting |
| Glasgow, United Kingdom | |
| Contact: Richard Molloy, MD, FRCS +44 1412113483 | |
| Sub-Investigator: Richard Molloy, MD, FRCS | |
| Leicester Royal Infirmary Hospital | Recruiting |
| Leicester, United Kingdom | |
| Contact: Andrew Miller, MD, FRCS +44 116 2586853 | |
| Sub-Investigator: Andrew Miller, MD, FRCS | |
| Freeman Hospital | Recruiting |
| Newcastle, United Kingdom | |
| Contact: Alan Horgan, MD, FRCS +44 191 2137420 | |
| Sub-Investigator: Alan Horgan, MD, FRCS | |
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 May 23, 2013