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.

Study Overview

• Status: Completed
• Conditions: Laparoscopy; Clinical Competence
• Intervention / Treatment: Behavioral: Training at actual laparoscopic surgery; Behavioral: Technical instruction; Behavioral: Training on laparoscopic simulator in skills lab

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Technical instruction; Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Progress of time to completion of test		After 3 weeks of individual training
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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. doi: 10.1007/s00464-011-1860-5. Epub 2011 Aug 19.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (Estimate): March 24, 2010

Study Record Updates

• Last Update Posted (Estimate): August 4, 2010
• Last Update Submitted That Met QC Criteria: August 3, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: StV 12-2008