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

6. oktober 2008 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Antrim, Det Forenede Kongerige
        • Rekruttering
        • Antrim Area Hospital
        • Kontakt:
          • Colman Byrnes, MD, FRCS
          • Telefonnummer: +44 028 9442 4000
        • Underforsker:
          • Colman Byrnes, Md, FRCS
      • Glasgow, Det Forenede Kongerige
        • Rekruttering
        • Gartnavel General Hospital
        • Kontakt:
          • Richard Molloy, MD, FRCS
          • Telefonnummer: +44 1412113483
        • Underforsker:
          • Richard Molloy, MD, FRCS
      • Leicester, Det Forenede Kongerige
        • Rekruttering
        • Leicester Royal Infirmary Hospital
        • Kontakt:
          • Andrew Miller, MD, FRCS
          • Telefonnummer: +44 116 2586853
        • Underforsker:
          • Andrew Miller, MD, FRCS
      • Newcastle, Det Forenede Kongerige
        • Rekruttering
        • Freeman Hospital
        • Kontakt:
          • Alan Horgan, MD, FRCS
          • Telefonnummer: +44 191 2137420
        • Underforsker:
          • Alan Horgan, MD, FRCS
  • Irland
      • Cork, Irland
        • Rekruttering
        • Mercy University Hospital
        • Kontakt:
          • Michael O'Riordain, MD, FRCS
          • Telefonnummer: +353 21 4935336
        • Underforsker:
          • Michael O'Riordain, MD, FRCSI
      • Dublin, Irland, 24
        • Rekruttering
        • AMNCH
        • Kontakt:
          • Dairmuid O'Riordain, MD, FRCSI
          • Telefonnummer: +353 1 414 2213
        • Underforsker:
          • Dairmuid O'Riordain, MD, FRCSI
      • Dublin, Irland, 4
        • Rekruttering
        • St. Vincent's University Hospital
        • Kontakt:
          • Desmond Winter, MD, FRCSI
          • Telefonnummer: +353 1 2214000
        • Underforsker:
          • Desmond Winter, MD, FRCSI
      • Dublin, Irland, 9
        • Rekruttering
        • Beaumont Hospital
        • Kontakt:
          • Deborah McNamara, MD, FRCSI
          • Telefonnummer: +353 1 8093000
        • Underforsker:
          • Deborah McNamara, MD, FRCSI
      • Dublin, Irland, Co. Dublin
        • Rekruttering
        • AMNCH
        • Kontakt:
          • Paul Neary, MD, FRCSI
          • Telefonnummer: +35314142000
        • Ledende efterforsker:
          • Paul Neary, MD, FRCSI
      • Tullamore, Irland, Co Offaly
        • Rekruttering
        • Tullamore general hospital
        • Kontakt:
          • Dermot Hehir, FRCSI
          • Telefonnummer: +35357 93 22206
        • Underforsker:
          • Dermot Hehir, FRCSI

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SC
Subjects (surgical trainees) randomised to train under a proficiency-based progression virtual reality simulation curriculum
Andet: 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
Andre navne:
  • Simulation Curriculum
  • SC
Aktiv komparator: CC
Subjects (surgical trainees) randomised to the current surgical training curriculum
Andet: 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.
Andre navne:
  • CC
  • Current Curriculum

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 6-12 months
6-12 months

Sekundære resultatmål

Resultatmål
Tidsramme
We aim to set the institutional and national proficiency level for Laparoscopic Assisted Colectomy (LAC) using the ProMIS-LAC simulator from Haptica, Ireland.
Tidsramme: 30 days
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Royal College of Surgeons, Ireland

Samarbejdspartnere

Health Service Executive

Efterforskere

  • Ledende efterforsker: Paul Neary, MD, FRCSI, Royal College of Surgeons in Ireland

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2008

Primær færdiggørelse (Forventet)

1. juni 2009

Studieafslutning (Forventet)

1. september 2009

Datoer for studieregistrering

Først indsendt

11. september 2008

Først indsendt, der opfyldte QC-kriterier

12. september 2008

Først opslået (Skøn)

15. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. oktober 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. oktober 2008

Sidst verificeret

1. oktober 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • RCSI 3

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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