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

Sponsor

Royal College of Surgeons, Ireland (Other)

Overall Status

Unknown status

CT.gov ID

NCT00752817

Collaborator

Health Service Executive (Other)

Enrollment

Locations

Arms

Duration (Months)

1.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Disease	Other: Proficiency-based virtual reality simulation training Other: Training under the current surgical training programme	N/A

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.

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;

Simulator Curriculum (SC) group.
Conventional Curriculum (CC) group.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

Creating and Implementing a Proficiency-Based Progression Virtual Reality Training Programme for Higher Surgical Trainees for Laparoscopic Assisted Sigmoid Colectomy.

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

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

Outcome Measures

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 [6-12 months]

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. [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	AMNCH	Dublin	Ireland	Co. Dublin
6	Tullamore general hospital	Tullamore	Ireland	Co Offaly
7	Antrim Area Hospital	Antrim	United Kingdom
8	Gartnavel General Hospital	Glasgow	United Kingdom
9	Leicester Royal Infirmary Hospital	Leicester	United Kingdom
10	Freeman Hospital	Newcastle	United Kingdom