LaparoscopyNCT01092013
Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices
A study testing Training on laparoscopic simulator in skills lab, Training at actual laparoscopic surgery and Technical instruction in people with Laparoscopy and Clinical Competence, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Laparoscopy, Clinical Competence
- What is being tested?
- Training on laparoscopic simulator in skills lab, Training at actual laparoscopic surgery and Technical instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Apr 2009
- 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
- Medical students on a surgical clerkship rotation at the department of visceral and transplantation surgery of the university hospital of Zurich, Switzerland
Who cannot join
- Any experience in laparoscopic camera handling in the OR and/or simulator based laparoscopic training
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Laparoscopy, Clinical Competence
- Being tested
- Training on laparoscopic simulator in skills lab, Training at actual laparoscopic surgery, Technical instruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on laparoscopic simulator in skills labBehavioural
Laparoscopic camera training in a skills lab following training protocol for a total of 6 hours during 3 weeks.
Training at actual laparoscopic surgeryBehavioural
Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks
Technical instructionBehavioural
Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Operating room training | Active comparator | Not described Receives: Behavioral: Training at actual laparoscopic surgery; Behavioral: Technical instruction |
| Skills lab training | Active comparator | Not described Receives: Behavioral: Training on laparoscopic simulator in skills lab; Behavioral: Technical instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3 weeks of individual training
Secondary outcomes (3)
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.
Measured: During 3 weeks of individual training
Progress of time to completion of test
Measured: 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.
Measured: After 3 weeks of individual training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionApr 2009
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 LaparoscopyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Florian M Franzeck, cand. med., Principal investigator, University of Zurich, Faculty of MedicineDieter Hahnloser, MD, Study director, University Hospital of Zurich, Departement of Visceral and Transplantation Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092013
- Sponsor's protocol ID
- StV 12-2008
- Status last verified
- Aug 2010
- First submitted
- 15 Mar 2010
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21853391
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices
- ClinicalTrials.gov ID
- NCT01092013
- Acronym / sponsor ID
- StV 12-2008
- Conditions
- Laparoscopy, Clinical Competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 24 Mar 2010 (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.
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
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students on a surgical clerkship rotation at the department of visceral and transplantation surgery of the university hospital of Zurich, Switzerland
Key exclusion criteria (1 listed)
- Any experience in laparoscopic camera handling in the OR and/or simulator based laparoscopic training
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 |
|---|---|---|
| Training on laparoscopic simulator in skills labLaparoscopic camera training in a skills lab following training protocol for a total of 6 hours during 3 weeks. | Behavioural | Skills lab training |
| Training at actual laparoscopic surgeryAssisting at 6 laparoscopic surgeries navigating the camera during 3 weeks | Behavioural | Operating room training |
| Technical instructionTechnical instruction on proper handling of an angled laparoscope before randomization for 1 hour | Behavioural | Operating room training, Skills lab training |
Primary outcome
Progress of skills shown in test regarding target centring as assessed by rating scale
Time frame: After 3 weeks of individual training
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.
3 secondary outcomes
Total time effort spend for respective training time
Time frame: During 3 weeks of individual training
Progress of time to completion of test
Time frame: After 3 weeks of individual training
Progress of skills shown in test regarding horizon alignment as assessed by rating scale
Time frame: After 3 weeks of individual training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2010.
- Derived from this study: PubMed 21853391Franzeck 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.
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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.
Florian M Franzeck, cand. med. principal investigator
University of Zurich, Faculty of Medicine
Dieter Hahnloser, MD study director
University Hospital of Zurich, Departement of Visceral and Transplantation Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on laparoscopic simulator in skills lab, Training at actual laparoscopic surgery and Technical instruction in people with Laparoscopy and Clinical Competence, run by University of Zurich at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress of skills shown in test regarding target centring as assessed by rating scale (time frame: After 3 weeks of individual training). 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 NCT01092013, 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 4 Aug 2010.