Urethrocystoscopy SkillsNCT00631761
Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills
A study testing educational workshop in people with Urethrocystoscopy Skills, run by University of Cincinnati at 1 site in United States.
Trial summary
Develop a tool to objectively quantify technical skills necessary to perform diagnostic cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS). Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or judged. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Urethrocystoscopy Skills
- What is being tested?
- educational workshop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2008
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All Obstetrics \& Gynecology and Urology resident physicians training at the University of Cincinnati
Who cannot join
- Any above resident with extensive training in cystoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Develop a tool to objectively quantify technical skills necessary to perform diagnostic cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).
Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or judged.
Develop an intervention (1.5 hour workshop) which can be replicated by other residency programs in order to enhance learning of diagnostic cystoscopy. The workshop should be adequate for practicing Gynecologists as well as they already have experience with diagnostic hysteroscopy which uses many of the same concepts.
Read the detailed description
The OSATS and a written examination will be used to assess residents skills and knowledge pertinent to diagnostic urethrocystoscopy. All residents will be tested on anatomic replica of human bladder for baseline competency using the above tools. Then approximately half will be randomly selected to undergo an educational intervention (a workshop teaching diagnostic urethrocystoscopy). As we are interested in short-term acquisition, about a week later all residents will be retested using the same methods. Grades on the exam will be kept confidential.
- Conditions
- Urethrocystoscopy Skills
- Being tested
- educational workshop, no intervention (usual resident activities)
- Keywords
- urethrocystoscopy, cystoscopy, objective structured assessment of surgical skills (OSATS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational workshopOther
Also called Objective structured assessment of surgical skills (OSATS), diagnostic cystoscopy,, urethrocystoscopy skills intervention, objective evaluation of procedure skills intervention,, educational workshops, cystoscopy classes, cystoscopy certificate
The intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas.
no intervention (usual resident activities)Other
usual activities
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas of the human bladder. Receives: Other: educational workshop |
| 2 | Placebo comparator | The control group will be instructed to read a urethrocystoscopy textbook chapter at home Receives: Other: no intervention (usual resident activities) |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure competency and change in urethrocystoscopy skills
Measured: 2 months
Secondary outcomes (1)
Establish validity and reliability of measurement tools (OSATS) used to evaluate urethrocystoscopy skills
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJun 2008
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 Urethrocystoscopy SkillsStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Investigators
- Sam Siddighi, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631761
- Sponsor's protocol ID
- Cystoscopy Project
- Status last verified
- Aug 2008
- First submitted
- 27 Feb 2008
- Last updated
- 19 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Siddighi S, Kleeman SD, Baggish MS, Rooney CM, Pauls RN, Karram MM. Effects of an educational workshop on performance of fourth-degree perineal laceration repair. Obstet Gynecol. 2007 Feb;109(2 Pt 1):289-94. doi: 10.1097/01.AOG.0000251499.18394.9f.
PubMed 17267826
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills
- ClinicalTrials.gov ID
- NCT00631761
- Acronym / sponsor ID
- Cystoscopy Project
- Conditions
- Urethrocystoscopy Skills
- Keywords
- urethrocystoscopy, cystoscopy, objective structured assessment of surgical skills (OSATS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Mar 2008 (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.
Develop a tool to objectively quantify technical skills necessary to perform diagnostic cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).
Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or judged.
Develop an intervention (1.5 hour workshop) which can be replicated by other residency programs in order to enhance learning of diagnostic cystoscopy. The workshop should be adequate for practicing Gynecologists as well as they already have experience with diagnostic hysteroscopy which uses many of the same concepts.
Detailed description
The OSATS and a written examination will be used to assess residents skills and knowledge pertinent to diagnostic urethrocystoscopy. All residents will be tested on anatomic replica of human bladder for baseline competency using the above tools. Then approximately half will be randomly selected to undergo an educational intervention (a workshop teaching diagnostic urethrocystoscopy). As we are interested in short-term acquisition, about a week later all residents will be retested using the same methods. Grades on the exam will be kept confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: educational workshopThe intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas of the human bladder. |
| 2 | Placebo comparator | Other: no intervention (usual resident activities)The control group will be instructed to read a urethrocystoscopy textbook chapter at home |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All Obstetrics \& Gynecology and Urology resident physicians training at the University of Cincinnati
Key exclusion criteria (1 listed)
- Any above resident with extensive training in cystoscopy
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 |
|---|---|---|
| educational workshopAlso: Objective structured assessment of surgical skills (OSATS), diagnostic cystoscopy,, urethrocystoscopy skills intervention, objective evaluation of procedure skills intervention,, educational workshops, cystoscopy classes, cystoscopy certificateThe intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas. | Other | 1 |
| no intervention (usual resident activities)usual activities | Other | 2 |
Primary outcome
measure competency and change in urethrocystoscopy skills
Time frame: 2 months
1 secondary outcome
Establish validity and reliability of measurement tools (OSATS) used to evaluate urethrocystoscopy skills
Time frame: 2 months
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 19 Aug 2008.
- Background: PubMed 17267826Siddighi S, Kleeman SD, Baggish MS, Rooney CM, Pauls RN, Karram MM. Effects of an educational workshop on performance of fourth-degree perineal laceration repair. Obstet Gynecol. 2007 Feb;109(2 Pt 1):289-94. doi: 10.1097/01.AOG.0000251499.18394.9f.
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.
Sam Siddighi, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational workshop in people with Urethrocystoscopy Skills, run by University of Cincinnati at 1 site 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 19 Aug 2008. 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 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?
measure competency and change in urethrocystoscopy skills (time frame: 2 months). 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 NCT00631761, 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 19 Aug 2008.