Diagnostic Self EvaluationNCT01799577
Comparison of 2-Dimensional and 3-Dimensional Laparoscopic Visions
An observational study of Diagnostic Self Evaluation, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Diagnostic Self Evaluation
- What is being tested?
- Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Dec 2013
- Phase
- Observational
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Medical doctors
Who may be able to join
- medical doctors
Who cannot join
- disabled person (about arms or vision problems)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Trainig and Research Hospital
Istanbul, 12345
About this study
Official title: Comparison of 2-Dimensional and New Generation 3-Dimensional Laparoscopic Visions In An Experimental Model
This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model.
Read the detailed description
7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study. Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks (touch the marked circle, pass the two circle with needle, pick-beads and place, grape the suture, move the needle from one instrument to another instrument, pick-and-place, cutting, three different suturing) in term of total task time and error number. Statistical Package Program was used to perform statistical analyses. The data were presented as arithmetic means and standard deviations were calculated in each group. A P value of <0.05 was considered to be statistically significant.
- Conditions
- Diagnostic Self Evaluation
- Being tested
- Laparoscopic surgery
- Keywords
- laparoscopy, accuracy, duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
Two methods will be compare
| Study group | Role | What they receive |
|---|---|---|
| Gynecologist | Gynecologist can use laparoscopic surgery. Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
In order to test whether the 3-D laparoscopy vision system is superior or not than the 2-D laparoscopic vision system.
We want to test the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model. 7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study. Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks in term of total task time and error number.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
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 Diagnostic Self EvaluationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- TANER USTA, M.D., Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799577
- Sponsor's protocol ID
- BEHGynobs-4
- Status last verified
- Dec 2013
- First submitted
- 13 Feb 2013
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Usta TA, Ozkaynak A, Kovalak E, Ergul E, Naki MM, Kaya E. An assessment of the new generation three-dimensional high definition laparoscopic vision system on surgical skills: a randomized prospective study. Surg Endosc. 2015 Aug;29(8):2305-13. doi: 10.1007/s00464-014-3949-0. Epub 2014 Nov 21.
PubMed 25414065
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2-Dimensional and New Generation 3-Dimensional Laparoscopic Visions In An Experimental Model
- ClinicalTrials.gov ID
- NCT01799577
- Acronym / sponsor ID
- BEHGynobs-4
- Conditions
- Diagnostic Self Evaluation
- Keywords
- laparoscopy, accuracy, duration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Feb 2013 (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 study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model.
Detailed description
7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study. Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks (touch the marked circle, pass the two circle with needle, pick-beads and place, grape the suture, move the needle from one instrument to another instrument, pick-and-place, cutting, three different suturing) in term of total task time and error number. Statistical Package Program was used to perform statistical analyses. The data were presented as arithmetic means and standard deviations were calculated in each group. A P value of <0.05 was considered to be statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecologist | – | Procedure: Laparoscopic surgeryGynecologist can use laparoscopic surgery. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Medical doctors
Key inclusion criteria (1 listed)
- medical doctors
Key exclusion criteria (1 listed)
- disabled person (about arms or vision problems)
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 |
|---|---|---|
| Laparoscopic surgeryTwo methods will be compare | Procedure or surgery | Gynecologist |
Primary outcome
In order to test whether the 3-D laparoscopy vision system is superior or not than the 2-D laparoscopic vision system.
Time frame: 15 days
We want to test the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model. 7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study. Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks in term of total task time and error number.
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 3 Jan 2014.
- Derived from this study: PubMed 25414065Usta TA, Ozkaynak A, Kovalak E, Ergul E, Naki MM, Kaya E. An assessment of the new generation three-dimensional high definition laparoscopic vision system on surgical skills: a randomized prospective study. Surg Endosc. 2015 Aug;29(8):2305-13. doi: 10.1007/s00464-014-3949-0. Epub 2014 Nov 21.
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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.
TANER USTA, M.D. principal investigator
Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Self Evaluation, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 Jan 2014. 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 Turkey (Türkiye). 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?
In order to test whether the 3-D laparoscopy vision system is superior or not than the 2-D laparoscopic vision system. (time frame: 15 days). 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 NCT01799577, 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 3 Jan 2014.