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

October 6, 2008 updated by: Royal College of Surgeons, Ireland

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Musallam A Al-Akash, MBBS, MRCSI
  • Phone Number: +35314022703
  • Email: malakash@rcsi.ie

Study Locations

  • Ireland
      • Cork, Ireland
        • Recruiting
        • Mercy University Hospital
        • Contact:
          • Michael O'Riordain, MD, FRCS
          • Phone Number: +353 21 4935336
        • Sub-Investigator:
          • Michael O'Riordain, MD, FRCSI
      • Dublin, Ireland, 24
        • Recruiting
        • AMNCH
        • Contact:
          • Dairmuid O'Riordain, MD, FRCSI
          • Phone Number: +353 1 414 2213
        • Sub-Investigator:
          • Dairmuid O'Riordain, MD, FRCSI
      • Dublin, Ireland, 4
        • Recruiting
        • St. Vincent's University Hospital
        • Contact:
          • Desmond Winter, MD, FRCSI
          • Phone Number: +353 1 2214000
        • Sub-Investigator:
          • Desmond Winter, MD, FRCSI
      • Dublin, Ireland, 9
        • Recruiting
        • Beaumont Hospital
        • Contact:
          • Deborah McNamara, MD, FRCSI
          • Phone Number: +353 1 8093000
        • Sub-Investigator:
          • Deborah McNamara, MD, FRCSI
      • Dublin, Ireland, Co. Dublin
        • Recruiting
        • AMNCH
        • Contact:
          • Paul Neary, MD, FRCSI
          • Phone Number: +35314142000
        • Principal Investigator:
          • Paul Neary, MD, FRCSI
      • Tullamore, Ireland, Co Offaly
        • Recruiting
        • Tullamore general hospital
        • Contact:
          • Dermot Hehir, FRCSI
          • Phone Number: +35357 93 22206
        • Sub-Investigator:
          • Dermot Hehir, FRCSI
  • United Kingdom
      • Antrim, United Kingdom
        • Recruiting
        • Antrim Area Hospital
        • Contact:
          • Colman Byrnes, MD, FRCS
          • Phone Number: +44 028 9442 4000
        • Sub-Investigator:
          • Colman Byrnes, Md, FRCS
      • Glasgow, United Kingdom
        • Recruiting
        • Gartnavel General Hospital
        • Contact:
          • Richard Molloy, MD, FRCS
          • Phone Number: +44 1412113483
        • Sub-Investigator:
          • Richard Molloy, MD, FRCS
      • Leicester, United Kingdom
        • Recruiting
        • Leicester Royal Infirmary Hospital
        • Contact:
          • Andrew Miller, MD, FRCS
          • Phone Number: +44 116 2586853
        • Sub-Investigator:
          • Andrew Miller, MD, FRCS
      • Newcastle, United Kingdom
        • Recruiting
        • Freeman Hospital
        • Contact:
          • Alan Horgan, MD, FRCS
          • Phone Number: +44 191 2137420
        • Sub-Investigator:
          • Alan Horgan, MD, FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • CC
  • Current Curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6-12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Collaborators

Health Service Executive

Investigators

  • Principal Investigator: Paul Neary, MD, FRCSI, Royal College of Surgeons in Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2008

Last Update Submitted That Met QC Criteria

October 6, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCSI 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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