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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT01092013
Collaborator
(none)
24
1
2
19
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Training on laparoscopic simulator in skills lab
  • Behavioral: Training at actual laparoscopic surgery
  • Behavioral: Technical instruction
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Progress of skills shown in test regarding target centring as assessed by rating scale [After 3 weeks of individual training]

    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

  1. Total time effort spend for respective training time [During 3 weeks of individual training]

    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.

  2. Progress of time to completion of test [After 3 weeks of individual training]

  3. Progress of skills shown in test regarding horizon alignment as assessed by rating scale [After 3 weeks of individual training]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01092013
Other Study ID Numbers:
  • StV 12-2008
First Posted:
Mar 24, 2010
Last Update Posted:
Aug 4, 2010
Last Verified:
Aug 1, 2010

Study Results

No Results Posted as of Aug 4, 2010