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

Colorectal Disease Clinical Trial

— LAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00752817
• Other study ID #: RCSI 3
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2008
• Last updated: October 6, 2008
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2008
• Source: Royal College of Surgeons, Ireland
• Contact: Musallam A Al-Akash, MBBS, MRCSI
• Phone: +35314022703
• Email: malakash[@]rcsi.ie
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Colorectal Disease

Intervention

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
• 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.

Locations

Country	Name	City	State
Ireland	Mercy University Hospital	Cork
Ireland	AMNCH	Dublin
Ireland	AMNCH	Dublin
Ireland	Beaumont Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin
Ireland	Tullamore general hospital	Tullamore
United Kingdom	Antrim Area Hospital	Antrim
United Kingdom	Gartnavel General Hospital	Glasgow
United Kingdom	Leicester Royal Infirmary Hospital	Leicester
United Kingdom	Freeman Hospital	Newcastle

Sponsors (2)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Health Service Executive

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No