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

Laparoscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092013
• Other study ID #: StV 12-2008
• Status: Completed
• Phase: N/A
• First received: March 15, 2010
• Last updated: August 3, 2010
• Start date: September 2007
• Est. completion date: April 2009

Study information

• Verified date: August 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Clinical Competence
• Laparoscopy

Intervention

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.
• Training at actual laparoscopic surgery
Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks
• Technical instruction
Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress of skills shown in test regarding target centring as assessed by rating scale	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.	After 3 weeks of individual training	No
Secondary	Total time effort spend for respective training time	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.	During 3 weeks of individual training	No
Secondary	Progress of time to completion of test		After 3 weeks of individual training	No
Secondary	Progress of skills shown in test regarding horizon alignment as assessed by rating scale	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.	After 3 weeks of individual training	No