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

NCT00752817 | Unknown DMC

• 1 other identifier: RCSI 3
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 10

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.

Conditions

Colorectal Disease

Keywords

Virtual Reality; Simulator; Proficiency; Laparoscopic; Colectomy; Education; Surgical Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

SC

EXPERIMENTAL

Subjects (surgical trainees) randomised to train under a proficiency-based progression virtual reality simulation curriculum

Other: Proficiency-based virtual reality simulation training

CC

ACTIVE COMPARATOR

Subjects (surgical trainees) randomised to the current surgical training curriculum

Other: Training under the current surgical training programme

Interventions

Proficiency-based virtual reality simulation training OTHER

Subjects (surgical trainees) will be trained under a proficiency-based virtual reality simulation training programme before performing their first live case

Also known as: Simulation Curriculum, SC

SC

Training under the current surgical training programme OTHER

Subjects (surgical trainees) will continue to train under the current training methodology offered at their institution before they perform their first live case.

Also known as: Current Curriculum, CC

CC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Health Service Executive: collaborator

Study Sites (10)

Mercy University Hospital

Cork, Ireland

RECRUITING

AMNCH

Dublin, 24, Ireland

RECRUITING

St. Vincent's University Hospital

Dublin, 4, Ireland

RECRUITING

Beaumont Hospital

Dublin, 9, Ireland

RECRUITING

AMNCH

Dublin, Co. Dublin, Ireland

RECRUITING

Tullamore general hospital

Tullamore, Co Offaly, Ireland

RECRUITING

Antrim Area Hospital

Antrim, United Kingdom

RECRUITING

Gartnavel General Hospital

Glasgow, United Kingdom

RECRUITING

Leicester Royal Infirmary Hospital

Leicester, United Kingdom

RECRUITING

Freeman Hospital

Newcastle, United Kingdom

RECRUITING

Related Publications (35)

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Study Officials

• Paul Neary, MD, FRCSI

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Musallam A Al-Akash, MBBS, MRCSI

CONTACT

+35314022703; malakash@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 7, 2008

Record last verified: 2008-10

Locations

GB (4); IE (6)