Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01092013
First received: March 15, 2010
Last updated: August 3, 2010
Last verified: August 2010

March 15, 2010
August 3, 2010
September 2007
April 2009   (final data collection date for primary outcome measure)
Progress of skills shown in test regarding target centring as assessed by rating scale [ Time Frame: After 3 weeks of individual training ] [ Designated as safety issue: No ]
Students are sent to the OR to do two camera assessment tests involving a standardized set of tasks they had to accomplish operation. They had to center and hold for 5 seconds the following positions/organs and had to maintain the correct horizontal alignment during camera movement: 1. Left abdominal wall, 2. Descending colon, 3. Right lobe of liver, 4. Sigmoid colon 5. Caecum 6. Pelvis 7. Trocar entry site in the upper left quadrant 8. Desc. Colon. This assessment was video-taped. A rating scale quantifying target centring was used.
  • Progress of skills shown in test as assessed by rating scale [ Time Frame: After 3 weeks of individual training ] [ Designated as safety issue: No ]
    Students are sent to the OR to do two camera assessment tests involving a standardized set of tasks they had to accomplish operation. They had to center and hold for 5 seconds the following positions/organs and had to maintain the correct horizontal alignment during camera movement: 1. Left abdominal wall, 2. Descending colon, 3. Right lobe of liver, 4. Sigmoid colon 5. Caecum 6. Pelvis 7. Trocar entry site in the upper left quadrant 8. Desc. Colon. This assessment was video-taped. A rating scale quantifying target centring and horizon alignment from 1-4 each was used.
  • Progress of time to completion of test [ Time Frame: After 3 weeks of individual training ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01092013 on ClinicalTrials.gov Archive Site
  • Total time effort spend for respective training time [ Time Frame: During 3 weeks of individual training ] [ Designated as safety issue: No ]

    Total time effort for OR group was defined as time used from receiving pager call (to go to OR) to leaving OR.

    Time effort for Skillslab group was defined as total time spend in Skillslab.

  • Progress of time to completion of test [ Time Frame: After 3 weeks of individual training ] [ Designated as safety issue: No ]
  • Progress of skills shown in test regarding horizon alignment as assessed by rating scale [ Time Frame: After 3 weeks of individual training ] [ Designated as safety issue: No ]
    Students are sent to the OR to do two camera assessment tests involving a standardized set of tasks they had to accomplish operation. They had to center and hold for 5 seconds the following positions/organs and had to maintain the correct horizontal alignment during camera movement: 1. Left abdominal wall, 2. Descending colon, 3. Right lobe of liver, 4. Sigmoid colon 5. Caecum 6. Pelvis 7. Trocar entry site in the upper left quadrant 8. Desc. Colon. This assessment was video-taped. A rating scale quantifying horizon alignment was used.
Total time effort spend for respective training time [ Time Frame: During 3 weeks of individual training ] [ Designated as safety issue: No ]

Total time effort for OR group was defined as time used from receiving pager call (to go to OR) to leaving OR.

Time effort for Skillslab group was defined as total time spend in Skillslab.

Not Provided
Not Provided
 
Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices
Not Provided

This prospective randomized study aims for determination whether focused simulator based laparoscopic camera training in novices can improve camera performance in an actual clinical situations in the same manner as traditional training in the OR does, especially considering efficient use of training time.

Medical students in their final years without any significant experience in handling an angled laparoscopic camera participate in the study and perform a camera guidance test in surgery. The participants are then randomized in two groups to receive either a simulator based or traditional in theatre training during three weeks. The camera test will be repeated, while both tests are going to be recorded. Videos of 14 camera tests carried out by laparoscopic experts are taped as well.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Laparoscopy
  • Clinical Competence
  • Behavioral: Training on laparoscopic simulator in skills lab
    Laparoscopic camera training in a skills lab following training protocol for a total of 6 hours during 3 weeks.
  • Behavioral: Training at actual laparoscopic surgery
    Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks
  • Behavioral: Technical instruction
    Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour
  • Active Comparator: Operating room training
    Interventions:
    • Behavioral: Training at actual laparoscopic surgery
    • Behavioral: Technical instruction
  • Active Comparator: Skills lab training
    Interventions:
    • Behavioral: Training on laparoscopic simulator in skills lab
    • Behavioral: Technical instruction
Franzeck FM, Rosenthal R, Muller MK, Nocito A, Wittich F, Maurus C, Dindo D, Clavien PA, Hahnloser D. Prospective randomized controlled trial of simulator-based versus traditional in-surgery laparoscopic camera navigation training. Surg Endosc. 2012 Jan;26(1):235-41. Epub 2011 Aug 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Medical students on a surgical clerkship rotation at the department of visceral and transplantation surgery of the university hospital of Zurich, Switzerland

Exclusion Criteria:

  • Any experience in laparoscopic camera handling in the OR and/or simulator based laparoscopic training
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01092013
StV 12-2008
Yes
Franzeck M Florian, cand. med., University of Zurich, Faculty of Medicine
University of Zurich
Not Provided
Principal Investigator: Florian M Franzeck, cand. med. University of Zurich, Faculty of Medicine
Study Director: Dieter Hahnloser, MD University Hospital of Zurich, Departement of Visceral and Transplantation Surgery
University of Zurich
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP