CholelithiasisNCT01615549
Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator
A study testing Laparsocopic cholecystectomy in people with Cholelithiasis and Cholecystitis, run by University of Zurich at 2 sites in Switzerland.
Trial summary
Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cholelithiasis, Cholecystitis, Cholecystolithiasis
- What is being tested?
- Laparsocopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2004to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Surgical novices (trainees / residents)
- Performed less than five laparoscopic procedures
- No previous simulator experience
Who cannot join
- Specialist surgeons
- Performed more than five laparoscopic procedures
- Previous experience with a simulator
Trial locations and contacts
2 sites in 1 country.
Martin W von Websky, MD contact
Switzerland2 sites, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Oliver M Fisher, MD
Dimitri A Raptis, MD, MSc, +41798820542, dimitri.raptis@usz.ch
- Active, not recruiting
University Hospital Zurich, Department of Surgery
Zurich, CH-8091
About this study
Official title: Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial
Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices.
Read the detailed description
Virtual reality simulators are widely accepted tools to familiarize surgical novices with the principles of laparoscopy without jeopardizing patient safety. However, access to a Virtual reality simulator and initial instruction alone followed by free training of the surgical novice may not be sufficient to achieve the training goals efficiently. The aims of this study are to determine if proficiency based laparoscopic training on the Simbionx LAP Mentor™ with external formative assessment using peer group derived benchmarks is superior to free training with self-assessment using the simulated laparoscopic cholecystectomy procedure with different endpoints (time to extract the gallbladder, serious complications, safe cautery and instrument pathways) as outcome parameters.
- Conditions
- Cholelithiasis, Cholecystitis, Cholecystolithiasis
- Being tested
- Laparsocopic cholecystectomy
- Keywords
- Cholecystectomy, Virtual reality device, Training
- Medical subject headings
- Cholelithiasis, Cholecystitis, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparsocopic cholecystectomyProcedure or surgery
Also called Key whole gall bladder surgery
Perform laparsocopic cholecystectomy on a virtual reality devise
| Study group | Role | What they receive |
|---|---|---|
| Free training | Active comparator | Not described Receives: Procedure: Laparsocopic cholecystectomy |
| Proficiency-based training | Experimental | Not described Receives: Procedure: Laparsocopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to extract the gall bladder.
The time to extract the gall bladder on a virtual simulator is typically 10 minutes. However this varies according to the settings of the difficulty chosen on the virtual reality software. This is a continuous variable measuring the duration for a trainee surgeon to extract the gall bladder (measured in seconds). The start point is the beginning of the exercise and the finishing point is once the gall bladder is completely resected (gall bladder mobilized and the cystic duct and artery dissected and ligated).
Measured: 10 minutes in average
Secondary outcomes (3)
Serious intra-operative complications
Serious complications on a virtual simulator are considered injuries to the bile duct, hepatic artery, the bowel, or the liver bed. Such complications are automatically detected by the virtual reality software and recorded in a special database. This is a continuous variable with "0" indicating no complications, "1" indicating one complication, "2" indicating two complications, etc.
Measured: 10 minutes in average
Safe cautery
During a virtual laparoscopic cholecycetoctomy, cautery (also know as a coagulator, a device that utilizes electrical current for dissection or bleeding control)is commonly used to mobilize the gall bladder away from the liver bed. The virtual simulator software measures the percentage of the unsafe use of cautery. This is a continuous variable with 100% safe cautery indicating no unsafe cauterization around important structures such as the bowel, bile duct, hepatic artery, etc.
Measured: 10 minutes in average
Total path length of right instrument
The total path length of the right instrument used to extract the gall bladder during a virtual laparoscopic cholecystectomy task measures the "in and out" movement of the right instrument. The higher the value, the more unnecessary movements are made during the task.
Measured: 10 minutes in average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startApr 2004
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn, University Hospital, Basel, Switzerland, University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Martin W von Websky, MD, Principal investigator, University Hospital Zurich, Department of SurgeryDimitri A Raptis, MD, MSc, Principal investigator, University Hospital Zurich, Department of SurgeryPierre-Alain Clavien, MD, PhD, Study chair, University Hospital, ZürichDieter Hahnloser, MD, Study director, University Hospital Zurich, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615549
- Sponsor's protocol ID
- Simbionix 20120507
- Other IDs
- SNSF 32003B-120722
- Status last verified
- Aug 2013
- First submitted
- 23 May 2012
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
von Websky MW, Raptis DA, Vitz M, Rosenthal R, Clavien PA, Hahnloser D. Access to a simulator is not enough: the benefits of virtual reality training based on peer-group-derived benchmarks--a randomized controlled trial. World J Surg. 2013 Nov;37(11):2534-41. doi: 10.1007/s00268-013-2175-6.
PubMed 23942532
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01615549
- Acronym / sponsor ID
- Simbionix 20120507
- Conditions
- Cholelithiasis, Cholecystitis, Cholecystolithiasis
- Keywords
- Cholecystectomy, Virtual reality device, Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Bonn, University Hospital, Basel, Switzerland, University of Lausanne Hospitals
- Study start
- Apr 2004
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices.
Detailed description
Virtual reality simulators are widely accepted tools to familiarize surgical novices with the principles of laparoscopy without jeopardizing patient safety. However, access to a Virtual reality simulator and initial instruction alone followed by free training of the surgical novice may not be sufficient to achieve the training goals efficiently. The aims of this study are to determine if proficiency based laparoscopic training on the Simbionx LAP Mentor™ with external formative assessment using peer group derived benchmarks is superior to free training with self-assessment using the simulated laparoscopic cholecystectomy procedure with different endpoints (time to extract the gallbladder, serious complications, safe cautery and instrument pathways) as outcome parameters.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free training | Active comparator | Procedure: Laparsocopic cholecystectomy |
| Proficiency-based training | Experimental | Procedure: Laparsocopic cholecystectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Surgical novices (trainees / residents)
- Performed less than five laparoscopic procedures
- No previous simulator experience
Key exclusion criteria (3 listed)
- Specialist surgeons
- Performed more than five laparoscopic procedures
- Previous experience with a simulator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparsocopic cholecystectomyAlso: Key whole gall bladder surgeryPerform laparsocopic cholecystectomy on a virtual reality devise | Procedure or surgery | Free training, Proficiency-based training |
Primary outcome
Time to extract the gall bladder.
Time frame: 10 minutes in average
The time to extract the gall bladder on a virtual simulator is typically 10 minutes. However this varies according to the settings of the difficulty chosen on the virtual reality software. This is a continuous variable measuring the duration for a trainee surgeon to extract the gall bladder (measured in seconds). The start point is the beginning of the exercise and the finishing point is once the gall bladder is completely resected (gall bladder mobilized and the cystic duct and artery dissected and ligated).
3 secondary outcomes
Serious intra-operative complications
Time frame: 10 minutes in average
Safe cautery
Time frame: 10 minutes in average
Total path length of right instrument
Time frame: 10 minutes in average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Derived from this study: PubMed 23942532von Websky MW, Raptis DA, Vitz M, Rosenthal R, Clavien PA, Hahnloser D. Access to a simulator is not enough: the benefits of virtual reality training based on peer-group-derived benchmarks--a randomized controlled trial. World J Surg. 2013 Nov;37(11):2534-41. doi: 10.1007/s00268-013-2175-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin W von Websky, MD contact
Martin W von Websky, MD principal investigator
University Hospital Zurich, Department of Surgery
Dimitri A Raptis, MD, MSc principal investigator
University Hospital Zurich, Department of Surgery
Pierre-Alain Clavien, MD, PhD study chair
University Hospital, Zürich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparsocopic cholecystectomy in people with Cholelithiasis and Cholecystitis, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin W von Websky, MD (martin@websky.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to extract the gall bladder. (time frame: 10 minutes in average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.