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

NCT01092013 | Completed DMC

• 1 other identifier: StV 12-2008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopy; Clinical Competence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total time effort spend for respective training time

  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

  After 3 weeks of individual training

Study Arms (2)

Operating room training

ACTIVE COMPARATOR

Behavioral: Training at actual laparoscopic surgery; Behavioral: Technical instruction

Skills lab training

ACTIVE COMPARATOR

Behavioral: Training on laparoscopic simulator in skills lab; Behavioral: Technical instruction

Interventions

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.

Skills lab training

Training at actual laparoscopic surgery BEHAVIORAL

Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks

Operating room training

Technical instruction BEHAVIORAL

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

Operating room training; Skills lab training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical students on a surgical clerkship rotation at the department of visceral and transplantation surgery of the university hospital of Zurich, Switzerland

You may not qualify if:

• Any experience in laparoscopic camera handling in the OR and/or simulator based laparoscopic training

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 21853391 DERIVED

Study Officials

• Florian M Franzeck, cand. med.

  University of Zurich, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Dieter Hahnloser, MD

  University Hospital of Zurich, Departement of Visceral and Transplantation Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 24, 2010
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: August 4, 2010

Record last verified: 2010-08

Locations

CH (1)