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OpenTrials
Completed

NCT Number: NCT01092013

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

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.

Completed

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Key information

Conditions

Laparoscopy Clinical Competence

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training on laparoscopic simulator in skills lab

Behavioral

Laparoscopic camera training in a skills lab following training protocol for a total of 6 hours during 3 weeks.

Training at actual laparoscopic surgery

Behavioral

Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks

Technical instruction

Behavioral

Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour

Primary outcomes

  1. Progress of skills shown in test regarding target centring as assessed by rating scale

    Time frame: 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 outcomes

  1. Total time effort spend for respective training time

    Time frame: 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

    Time frame: After 3 weeks of individual training

  3. Progress of skills shown in test regarding horizon alignment as assessed by rating scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 24, 2010
Registry last updated
Aug 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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