Surgical Procedure, UnspecifiedNCT00555243
Laparoscopic Simulator Training and Its Impact on Surgical Education
A study testing Laparoscopic Simulation training and Traditional Surgical Education in people with Surgical Procedure, Unspecified and Surgical Simulation, run by University of Texas Southwestern Medical Center at 4 sites in United States.
Trial summary
The primary goal of this study is to answer whether validated laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified, Surgical Simulation
- What is being tested?
- Laparoscopic Simulation training and Traditional Surgical Education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2005to Jan 2011
- 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
- All Ob/Gyn residents in post-graduate years 1-4 from ACGME accredited programs
Who cannot join
- none
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama at Birmingham Department of Ob/Gyn
Birmingham, Alabama, 35243
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Texas at Houston Department of Ob/Gyn
Houston, Texas, 77026
Uniformed Services University of the Health Sciences
Washington D.C., District of Columbia, 20307
About this study
Official title: An Evaluation of Validated Laparoscopic Skills Simulators and the Impact on Operating Room Performance
The primary goal of this study is to answer whether validated laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents.
Read the detailed description
We have designed a randomized control trial to assess the impact of a laparoscopic simulator curriculum on operating room performance amongst gynecology residents. At the beginning of the study, each resident that chooses to participate will take a multiple choice pre-test assessing his or her background knowledge of laparoscopic surgical principles. Everyone will then listen to a series of lectures / video demonstrations teaching the fundamentals of laparoscopic surgery. The final part of the orientation is to have each resident perform 5 tasks on the laparoscopic simulators (peg transfer, endoloop, pattern cutting, intracorporeal suturing, and extracorporeal suturing) while being proctored by a faculty member who is timing the task and recording any errors made. Each resident will have 2 proctored performances (pre- and post) on the simulator and it will be set up as a typical OSCE-type exam. We chose to have them perform 2 repetitions as opposed to the usual 1 (like on the MCAT, SAT, or other high stake exam) to allow for potential unfamiliarity with the simulator equipment.
The residents will then perform a laparoscopic tubal ligation with a faculty member when they begin their Benign Gynecology rotation. Each resident will subsequently be randomized either traditional teaching (no simulator) or five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab. Those randomized to simulation training can practice and perform as many repetitions necessary on the simulator to achieve proficiency. Prior to completing the rotation, the residents will perform another laparoscopic tubal ligation with a faculty member blinded to whether they randomized to simulator training to re-assess their technical skills. The resident will have another proctored examination of simulator performance on the five tasks. Finally, a videotape review by independent observers will verify precision of the surgical evaluations at the conclusion of the study.
- Being tested
- Laparoscopic Simulation training, Traditional Surgical Education
- Keywords
- Laparoscopic Surgical Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Simulation trainingProcedure or surgery
Also called Fundamentals of Laparoscopic Surgery
five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab
Traditional Surgical EducationProcedure or surgery
Traditional surgical teaching (no simulator)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Laparoscopic Simulation Education Receives: Procedure: Laparoscopic Simulation training |
| 2 | Placebo comparator | Not described Receives: Procedure: Traditional Surgical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents
Measured: Over the course of one resident rotation (4-6 weeks)
Secondary outcomes (3)
Determine if the level of improvement is inversely related to resident level of training.
Measured: Over the course of one resident rotation (4-6 weeks)
Calculate receiver operator curves to aid in the establishment of a "passing score" threshold on the validated laparoscopic simulators
Measured: Over the course of one resident rotation (4-6 weeks)
Establish whether psychomotor testing predicts surgical proficiency and helps identify those who may need more intensive training over the course of their education.
Measured: Over the course of one resident rotation (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startAug 2005
- Primary completionJan 2011
- Study completionJan 2011
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 Surgical Procedure, UnspecifiedStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ochsner Health System, University of Alabama at Birmingham, The University of Texas Health Science Center, Houston, Uniformed Services University of the Health Sciences, Orlando Health, Inc., Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Rajiv B Gala, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555243
- Sponsor's protocol ID
- UTSW IRB 042006-034
- Status last verified
- Nov 2007
- First submitted
- 6 Nov 2007
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gala R, Orejuela F, Gerten K, Lockrow E, Kilpatrick C, Chohan L, Green C, Vaught J, Goldberg A, Schaffer J. Effect of validated skills simulation on operating room performance in obstetrics and gynecology residents: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):578-584. doi: 10.1097/AOG.0b013e318283578b.
PubMed 23635621
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Validated Laparoscopic Skills Simulators and the Impact on Operating Room Performance
- ClinicalTrials.gov ID
- NCT00555243
- Acronym / sponsor ID
- UTSW IRB 042006-034
- Keywords
- Laparoscopic Surgical Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Ochsner Health System, University of Alabama at Birmingham, The University of Texas Health Science Center, Houston, Uniformed Services University of the Health Sciences, Orlando Health, Inc., Virginia Commonwealth University
- Study start
- Aug 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Nov 2007 (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.
The primary goal of this study is to answer whether validated laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents.
Detailed description
We have designed a randomized control trial to assess the impact of a laparoscopic simulator curriculum on operating room performance amongst gynecology residents. At the beginning of the study, each resident that chooses to participate will take a multiple choice pre-test assessing his or her background knowledge of laparoscopic surgical principles. Everyone will then listen to a series of lectures / video demonstrations teaching the fundamentals of laparoscopic surgery. The final part of the orientation is to have each resident perform 5 tasks on the laparoscopic simulators (peg transfer, endoloop, pattern cutting, intracorporeal suturing, and extracorporeal suturing) while being proctored by a faculty member who is timing the task and recording any errors made. Each resident will have 2 proctored performances (pre- and post) on the simulator and it will be set up as a typical OSCE-type exam. We chose to have them perform 2 repetitions as opposed to the usual 1 (like on the MCAT, SAT, or other high stake exam) to allow for potential unfamiliarity with the simulator equipment.
The residents will then perform a laparoscopic tubal ligation with a faculty member when they begin their Benign Gynecology rotation. Each resident will subsequently be randomized either traditional teaching (no simulator) or five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab. Those randomized to simulation training can practice and perform as many repetitions necessary on the simulator to achieve proficiency. Prior to completing the rotation, the residents will perform another laparoscopic tubal ligation with a faculty member blinded to whether they randomized to simulator training to re-assess their technical skills. The resident will have another proctored examination of simulator performance on the five tasks. Finally, a videotape review by independent observers will verify precision of the surgical evaluations at the conclusion of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Laparoscopic Simulation trainingLaparoscopic Simulation Education |
| 2 | Placebo comparator | Procedure: Traditional Surgical Education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All Ob/Gyn residents in post-graduate years 1-4 from ACGME accredited programs
Key exclusion criteria (1 listed)
- none
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 Simulation trainingAlso: Fundamentals of Laparoscopic Surgeryfive 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab | Procedure or surgery | 1 |
| Traditional Surgical EducationTraditional surgical teaching (no simulator) | Procedure or surgery | 2 |
Primary outcome
Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents
Time frame: Over the course of one resident rotation (4-6 weeks)
3 secondary outcomes
Determine if the level of improvement is inversely related to resident level of training.
Time frame: Over the course of one resident rotation (4-6 weeks)
Calculate receiver operator curves to aid in the establishment of a "passing score" threshold on the validated laparoscopic simulators
Time frame: Over the course of one resident rotation (4-6 weeks)
Establish whether psychomotor testing predicts surgical proficiency and helps identify those who may need more intensive training over the course of their education.
Time frame: Over the course of one resident rotation (4-6 weeks)
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 21 Jan 2013.
- Derived from this study: PubMed 23635621Gala R, Orejuela F, Gerten K, Lockrow E, Kilpatrick C, Chohan L, Green C, Vaught J, Goldberg A, Schaffer J. Effect of validated skills simulation on operating room performance in obstetrics and gynecology residents: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):578-584. doi: 10.1097/AOG.0b013e318283578b.
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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.
Rajiv B Gala, MD principal investigator
University of Texas Southwestern Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Simulation training and Traditional Surgical Education in people with Surgical Procedure, Unspecified and Surgical Simulation, run by University of Texas Southwestern Medical Center at 4 sites in United States.
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 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents (time frame: Over the course of one resident rotation (4-6 weeks)). 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 NCT00555243, 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 21 Jan 2013.