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

NCT ID: NCT01092013

Last Updated: 2010-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laparoscopy Clinical Competence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Operating room training

Group Type ACTIVE_COMPARATOR

Training at actual laparoscopic surgery

Intervention Type BEHAVIORAL

Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks

Technical instruction

Intervention Type BEHAVIORAL

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

Skills lab training

Group Type ACTIVE_COMPARATOR

Training on laparoscopic simulator in skills lab

Intervention Type BEHAVIORAL

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

Technical instruction

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Training at actual laparoscopic surgery

Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks

Intervention Type BEHAVIORAL

Technical instruction

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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University of Zurich, Faculty of Medicine

Principal Investigators

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Florian M Franzeck, cand. med.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, Faculty of Medicine

Dieter Hahnloser, MD

Role: STUDY_DIRECTOR

University Hospital of Zurich, Departement of Visceral and Transplantation Surgery

Locations

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University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 21853391 (View on PubMed)

Other Identifiers

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StV 12-2008

Identifier Type: -

Identifier Source: org_study_id

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