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
  Purpose

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.


Condition Intervention
Laparoscopy
Clinical Competence
Behavioral: Training on laparoscopic simulator in skills lab
Behavioral: Training at actual laparoscopic surgery
Behavioral: Technical instruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: September 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Operating room training 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: Skills lab training 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: Technical instruction
Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092013

Locations
Switzerland
University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Franzeck M Florian, cand. med., University of Zurich, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01092013     History of Changes
Other Study ID Numbers: StV 12-2008
Study First Received: March 15, 2010
Last Updated: August 3, 2010
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on August 21, 2014