NCT00631761

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 19, 2008

Status Verified

August 1, 2008

Enrollment Period

1 month

First QC Date

February 27, 2008

Last Update Submit

August 18, 2008

Conditions

Keywords

urethrocystoscopycystoscopyobjective structured assessment of surgical skills (OSATS)

Outcome Measures

Primary Outcomes (1)

  • measure competency and change in urethrocystoscopy skills

    2 months

Secondary Outcomes (1)

  • Establish validity and reliability of measurement tools (OSATS) used to evaluate urethrocystoscopy skills

    2 months

Study Arms (2)

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.

Other: educational workshop

2

PLACEBO COMPARATOR

The control group will be instructed to read a urethrocystoscopy textbook chapter at home

Other: no intervention (usual resident activities)

Interventions

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.

Also known as: Objective structured assessment of surgical skills (OSATS), diagnostic cystoscopy,, urethrocystoscopy skills intervention, objective evaluation of procedure skills intervention,, educational workshops, cystoscopy classes, cystoscopy certificate
1

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All Obstetrics \& Gynecology and Urology resident physicians training at the University of Cincinnati

You may not qualify if:

  • Any above resident with extensive training in cystoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnat

Cincinnati, Ohio, 45202, United States

Location

Related Publications (1)

  • 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.

    PMID: 17267826BACKGROUND

Study Officials

  • Sam Siddighi, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 10, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 19, 2008

Record last verified: 2008-08

Locations